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Evidence: MediumProtein, not a peptideNot FDA ApprovedRecombinant endostatin with nine extra amino acidsApproved in China for lung cancer, 2005Given by infusion with chemotherapy; not approved in the US or EU

Recombinant Human Endostatin

The Chinese anti-angiogenic drug made from a fragment of collagen XVIII: how it was approved, what its trials show, and how it is given

Endostatin is a fragment of collagen XVIII that blocks the growth of new blood vessels. Discovered in 1997, it proved too insoluble and costly to develop as a drug in the West. Chinese scientists refolded it into a soluble, stable form with nine extra amino acids, sold as Endostar, and China's regulator approved it in 2005 for advanced non-small-cell lung cancer after a placebo-controlled phase 3 trial with vinorelbine and cisplatin. Since then it has been tested, almost entirely in China, alongside chemotherapy, radiotherapy and immunotherapy in many cancers. It is given by intravenous infusion and has no US or EU approval.

Used in human trials: 7.5 mg/m² once daily, Days 1 to 14 of each 3-week cycle, Not stated in the abstract (Phase 3: advanced NSCLC with vinorelbine and cisplatin (493 patients)) Details ↓

Overview

What is it?

Tumours need new blood vessels to grow beyond a small size, and in the 1990s the laboratory of Judah Folkman found that the body makes its own brakes on that process. Endostatin, a fragment of collagen XVIII first isolated in 1997, was one of the strongest, reported to cut sharply the formation of tumour blood vessels. As a drug it ran into practical problems. The protein was insoluble and unstable, and making it was expensive, so Western development stalled. Chinese scientists found a way to refold it with nine extra amino acids that make it soluble and stable, and called the product Endostar.

In laboratory tests Endostar does what endostatin is supposed to do. It slowed the growth, movement and tube-forming of human endothelial cells stimulated by VEGF, the main growth signal for new vessels, by blocking activation of the VEGF receptor VEGFR-2 and the signals downstream of it. It stopped vessels sprouting from rat aorta rings and new capillaries forming in chick embryo membranes. In mice carrying human lung tumours, it added to the effect of radiotherapy.

The trial that led to approval randomised 493 patients with advanced non-small-cell lung cancer to vinorelbine and cisplatin with either Endostar or placebo, two to one. The response rate rose from 19.5% to 35.4%, and the median time to progression from 3.6 to 6.3 months, without more severe side effects; long-term follow-up reported longer overall survival. China's drug regulator approved it in September 2005. An earlier randomised trial compared two daily doses and found no difference between them, so the lower dose, 7.5 mg per square metre of body surface, became the standard.

Since then the drug has been tested with chemotherapy, radiotherapy and newer immunotherapy in lung, breast, oesophageal, cervical, nasopharyngeal and colorectal cancers, in brain metastases, in fluid collecting around the lungs, and even to calm radiation damage to the lungs. Many results are positive, including a phase 3 trial of 803 women with breast cancer, where adding it to chemotherapy before surgery raised the response rate from 78% to 91%. But not all are. In extensive small-cell lung cancer, a randomised phase 2 trial found no gain in survival or progression, and a phase 2 trial of continuous infusion with chemoradiotherapy did not lengthen median progression-free survival. Meta-analyses pool mostly small, open-label Chinese trials, and some include non-randomised studies, which makes their favourable results less certain.

Two ways of giving it are used in China: a daily infusion over a few hours for about two weeks of each three-week cycle, or a continuous infusion by pump over several days. A pooled analysis suggests the continuous route has fewer heart and blood-count side effects, though the evidence quality was low to moderate. Neither the US FDA's drug database nor the European Medicines Agency's medicines list holds any record of it. It is an infused hospital cancer drug used with chemotherapy, not a stand-alone treatment, and the native endostatin made in the body is a different product.

35.4% vs 19.5%
Response rate with Endostar plus chemotherapy vs placebo plus chemotherapy
Phase 3, advanced NSCLC, 486 assessable patients · PMID 28920215
6.3 vs 3.6 mo
Median time to progression
Same phase 3 trial · PMID 21108883
7.5 mg/m²
Daily dose used in most trials
Lower of two doses compared in phase 2 · PMID 16750022
Science

Mechanism of Action

Rh-endostatin is a stabilised version of the body's own anti-angiogenic collagen fragment; it starves tumours of new blood vessels by blocking VEGF signalling in endothelial cells.

🩸

Blocks VEGF receptor signalling

It suppresses VEGF-triggered activation of VEGFR-2 and of ERK, p38 MAPK and AKT in endothelial cells (PMID 17644065).

🚫

Stops new vessel growth

Endothelial cells grow, migrate and form tubes less, and new capillaries fail to form in laboratory models (PMID 17644065).

☢️

Works with radiotherapy and chemotherapy

In mice it added to radiotherapy and lowered bFGF and VEGF in tumours; in patients it is always given alongside other cancer treatment (PMIDs 20155466, 21108883).

Evidence

Published Research

These are studies in which rh-endostatin (Endostar) itself was given, read from their PubMed abstracts: the laboratory and mouse work behind it, the lung cancer trials that led to approval, later trials in other cancers and settings, dosing and infusion-route studies, meta-analyses and reviews. Almost all were carried out in China, and most were open-label.

In Vitro2007

How it blocks new vessels

Endostar slowed VEGF-driven growth, migration and tube formation of human umbilical vein endothelial cells, stopped sprouting from rat aortic rings, and inhibited capillary growth in chick embryo membranes and tumours. It suppressed VEGF-triggered activation of VEGFR-2 and of ERK, p38 MAPK and AKT, and reduced the amount of VEGFR-2.

PMID: 17644065
Animal2010

Adds to radiotherapy in mice with lung tumours

In nude mice carrying human A549 lung adenocarcinoma, Endostar plus radiotherapy inhibited tumour growth more than either alone, raised tumour cell death, and lowered tumour levels of the growth factors bFGF and VEGF.

PMID: 20155466
Human2004

First randomised look in lung cancer

In 18 patients with stage IIIB-IV non-small-cell lung cancer, adding YH-16 to vinorelbine and cisplatin gave a response rate of 22% against 0% (not significant), a clinical benefit rate of 100% against 44%, and a longer time to progression, with no difference in toxicity.

PMID: 21241552
Human2006

Two doses, no difference

In 60 evaluable patients with previously treated advanced non-small-cell lung cancer given a daily 3-hour infusion for 28 days, 7.5 and 15 mg/m² gave the same 3% response rate and similar time to progression and side effects, so the lower dose was recommended.

PMID: 16750022
Human2005

The phase 3 trial behind approval

In 493 patients with stage IIIB-IV non-small-cell lung cancer randomised to vinorelbine and cisplatin with YH-16 or placebo every three weeks, the response rate was 35.4% against 19.5%, median time to progression 6.3 against 3.6 months, and clinical benefit 73.3% against 64.0%.

PMID: 21108883
Human2013

Long-term results of the phase 3 trial

With 322 patients on Endostar and 164 on placebo, severe neutropenia, anaemia and nausea occurred at similar rates in both arms, there were two treatment-related deaths with Endostar and one with placebo, and median overall survival was longer with Endostar.

PMID: 28920215
Human2015

No survival gain in small-cell lung cancer

In 140 Chinese patients with extensive-stage small-cell lung cancer, adding rh-endostatin to etoposide and carboplatin, then continuing it alone, did not improve progression-free survival (6.4 against 5.9 months), overall survival (12.1 against 12.4 months) or response rate, though quality-of-life scores improved.

PMID: 25654728
Human2018

Phase 3 in breast cancer before surgery

In 803 women randomised to neoadjuvant docetaxel and epirubicin with or without rh-endostatin, objective response after three cycles was 91.0% against 77.9% and complete response 14.2% against 6.7%; pathological complete response did not differ significantly, nor did side effects or quality of life.

PMID: 29238974
Human2013

Phase 2 in breast cancer before surgery

Among 68 women given three cycles of docetaxel and epirubicin, adding rh-endostatin at 7.5 mg/m² on days 1 to 14 raised the objective response rate from 67.7% to 90.9%; a retrospective subset analysis suggested more benefit in premenopausal women.

PMID: 23693018
Human2020

Longer survival in stage III breast cancer

In 87 women randomised to neoadjuvant docetaxel, epirubicin and cyclophosphamide with or without recombinant endostatin, response rose from 58% to 82%, and after a median of 54 months relapse-free and overall survival were longer in the endostatin group.

PMID: 32482525
Human2015

Phase 1: continuous infusion with FOLFOX

Twenty-one patients with advanced colorectal cancer received continuous infusion on days 4 to 14 at doses rising from 7.5 to 75 mg/m² a day with modified FOLFOX6. The maximum tolerated dose was 75 mg/m² a day; two patients stopped for heart rhythm problems, ECG changes were mostly ST and T wave changes, and exposure rose in proportion to dose up to 30 mg/m².

PMID: 25572362
Human2015

With chemoradiotherapy in stage III lung cancer

Forty-eight assessable patients with unresectable stage III non-small-cell lung cancer received Endostar for 7 days in weeks 1, 3, 5 and 7 with docetaxel, cisplatin and chest radiotherapy. The response rate was 77%, median progression-free survival 9.9 months and median overall survival 24.0 months, with tolerable toxicity.

PMID: 25497558
Human2019

HELPER: continuous infusion did not lengthen progression-free survival

Sixty-seven evaluable patients with unresectable stage III non-small-cell lung cancer received continuous Endostar infusions with etoposide, cisplatin and radiotherapy. The response rate was 76.1% and median overall survival 34.7 months, but median progression-free survival (13.3 months) was not prolonged; 58.2% had grade 3 or worse side effects, mostly low white cell counts.

PMID: 30773184
Human2020

Daily injection versus continuous pump

Comparing two phase 2 cohorts with unresectable stage III lung cancer, 48 given daily intravenous Endostar and 67 given a 120-hour continuous infusion with chemoradiotherapy, median progression-free survival (9.9 against 15.4 months) and overall survival (24.0 against 38.5 months) were numerically longer with the pump, but not significantly.

PMID: 32068962
Human2022

Around radiotherapy, a retrospective comparison

In patients with unresectable stage III-IV lung cancer having radiotherapy, those given rh-endostatin throughout had longer median progression-free survival (8.0 against 4.4 months) and overall survival (40.0 against 13.1 months) than those not given it; the study was retrospective and not randomised.

PMID: 34986655
Human2022

Brain metastases with whole-brain radiation

In 43 patients with brain metastases from non-small-cell lung cancer, adding rh-endostatin to whole-brain radiotherapy lengthened median progression-free survival (8.1 against 4.9 months) and intracranial progression-free survival; the overall survival difference (14.2 against 6.4 months) was not significant.

PMID: 35788355
Human2025

Fewer relapses of radiation pneumonitis

In 40 lung cancer patients with grade 2 or worse radiation pneumonitis, adding rh-endostatin to steroids cut the relapse rate from 45% to 15% and pneumonitis deaths from 35% to 5%, with no difference in adverse events.

PMID: 41014160
Human2022

Second-line in oesophageal cancer

In 50 patients with advanced oesophageal squamous cell carcinoma given 15 mg/m² rh-endostatin by 7-day continuous pump with irinotecan and cisplatin, 26% responded, median progression-free survival was 4.0 months and overall survival 12.3 months; 24% had grade 3 or worse side effects.

PMID: 35380726
Human2022

Cervical cancer with chemoradiotherapy

In 116 women with locally advanced cervical cancer, adding Endostar to cisplatin chemoradiotherapy gave similar toxicity; the two-year progression-free survival difference (80.8% against 63.5%) was not significant, but distant metastasis-free survival was better.

PMID: 34544526
Human2020

Nasopharyngeal cancer: long-term follow-up

In 114 patients with stage III-IVb nasopharyngeal carcinoma from three centres, adding Endostar at 7.5 mg/m² for two-week courses during induction chemotherapy and chemoradiotherapy did not increase toxicity, caused no bleeding or clotting problems, and after a median 67 months improved complete remission of neck lymph node disease (91.1% against 72.4%).

PMID: 32035692
Human2026

With the PD-L1 antibody envafolimab

In a single-arm phase 2 trial of 33 untreated patients with PD-L1-positive advanced non-small-cell lung cancer, envafolimab plus rh-endostatin gave a response rate of 48.5% and median progression-free survival of 12.3 months; six patients had grade 3 treatment-related side effects and none had grade 4 or 5.

PMID: 42216493
Review2018

Meta-analysis of Endostar with vinorelbine and cisplatin

Fifteen prospective studies showed a higher response rate (risk ratio 1.74) and one-year survival with Endostar added to vinorelbine and cisplatin, with no significant increase in low white cells, low platelets or nausea.

PMID: 29575575
Review2012

Meta-analysis with platinum doublets

Across 15 studies, adding Endostar to platinum-based two-drug chemotherapy for advanced non-small-cell lung cancer raised response and disease control rates by about 14 percentage points and improved time to progression and quality of life, with similar side effects.

PMID: 22917490
Review2021

Meta-analysis with chemoradiotherapy

Ten studies with 716 patients with locally advanced non-small-cell lung cancer found higher response and disease control rates and a modestly higher one-year survival rate when Endostar was added to concurrent chemoradiotherapy.

PMID: 34676669
Review2016

Into the chest for malignant pleural effusion

Thirteen randomised trials with 1,066 patients showed that Endostar infused into the chest with chemotherapy controlled malignant pleural effusions better than chemotherapy alone, with better quality of life.

PMID: 27842514
Review2020

Continuous versus intermittent infusion

Nine studies with 597 patients, only two randomised, found similar response rates with continuous and intermittent infusion; very low quality evidence favoured continuous infusion for survival, and moderate quality evidence showed less bone-marrow suppression and heart toxicity with it.

PMID: 33087103
Review2018

History, approval and dosing review

This review explains how Chinese scientists refolded endostatin into a soluble, stable form, states that China's regulator approved Endostar in September 2005 for non-small-cell lung cancer, and summarises its use, doses, routes, schedules and safety across cancers.

PMID: 32700135
Review2023

Endostatin as a cheaper anti-angiogenic option

This review places recombinant endostatin among anti-angiogenic drugs, notes that endostatin has made little progress as a cancer drug three decades after its discovery despite low toxicity, and dates the Chinese approval to 2006, a year later than other sources.

PMID: 38123873
Dosing

Dosing Data

Rh-endostatin is approved in China but has no US label, so there is no FDA dosing. These are the schedules stated in the abstracts of published human trials, all given intravenously in hospital alongside chemotherapy or radiotherapy.

These are hospital cancer-treatment schedules, given with chemotherapy or radiotherapy under specialist care, not recommendations. Doses are per square metre of body surface area. See a doctor before using any peptide.
ProtocolDoseFrequencyDurationRoute
Phase 3: advanced NSCLC with vinorelbine and cisplatin (493 patients) Human studyPMID 211088837.5 mg/m² once dailyDays 1 to 14 of each 3-week cycle2 to 6 cyclesNot stated in the abstract
Phase 2 dose comparison: pretreated advanced NSCLC (68 patients) Human studyPMID 167500227.5 or 15 mg/m² daily (7.5 recommended)Daily 3-hour infusion28 daysIntravenous
Phase 2: stage III NSCLC with chemoradiotherapy, continuous pump (HELPER) Human studyPMID 307731847.5 mg/m² per 24 hoursContinuous infusion for 120 hoursFour cycles of 14 daysIntravenous (continuous pump)
Phase 1: advanced colorectal cancer with modified FOLFOX6 (21 patients) Human studyPMID 255723627.5 to 75 mg/m² per day, escalated (maximum tolerated 75)Continuous infusion, days 4 to 14Per chemotherapy cycleIntravenous (continuous)

Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.

Doses by body surface area
Every dose here is milligrams per square metre of body surface, the way chemotherapy is dosed, given by infusion in hospital; none is a self-injected amount.
Open Calculator →
For Buyers

What a Buyer Needs to Know

What is sold, how it is mixed, stored and taken, and what is known about its safety, quality and legal status. Each part names its source. Where we have none, it says unknown.

What is sold

Unknown: we hold no label and no published test that says what forms or vial sizes Recombinant Human Endostatin is sold in. A vial's own label is a seller's claim, not a source.

Mixing a vial: a worked example

No worked example: none of the doses on this page is a fixed amount in mg or mcg injected under the skin or into a muscle (the routes given are: intravenous, intravenous (continuous pump), intravenous (continuous), not stated in the abstract). There is no home-mixing step to show. The reconstitution calculator does the arithmetic for any vial.

Source: the route and amount of each dose row in Dosing Data below.

Storage before and after mixing

Unknown: no label or published stability study on file says how to store Recombinant Human Endostatin, before or after mixing. The mixing guide sets out the general rules, with their sources: keep a mixed vial in the fridge, and use it promptly, as the bacteriostatic water label says of any drug dissolved in it. The 28 days often quoted is the limit for an opened multiple-dose vial from a manufacturer, an outer limit set for sterility, not a time a mixed solution has been shown to keep. Nobody has published how long Recombinant Human Endostatin stays intact once mixed.

How it is taken

As it was given in human studies: Not stated in the abstract (Days 1 to 14 of each 3-week cycle; Phase 3: advanced NSCLC with vinorelbine and cisplatin (493 patients)); Intravenous (Daily 3-hour infusion; Phase 2 dose comparison: pretreated advanced NSCLC (68 patients)); Intravenous (continuous pump) (Continuous infusion for 120 hours; Phase 2: stage III NSCLC with chemoradiotherapy, continuous pump (HELPER)); Intravenous (continuous) (Continuous infusion, days 4 to 14; Phase 1: advanced colorectal cancer with modified FOLFOX6 (21 patients)).

For injection technique, sites and needle disposal, see the mixing guide.

Source: Used in human trials: the route and frequency of each row in Dosing Data below.

What to expect, and when

How long it stays in the body: not established by a measurement cited on this entry.

How long the doses were given: Phase 3: advanced NSCLC with vinorelbine and cisplatin (493 patients): 2 to 6 cycles; Phase 2 dose comparison: pretreated advanced NSCLC (68 patients): 28 days; Phase 2: stage III NSCLC with chemoradiotherapy, continuous pump (HELPER): Four cycles of 14 days.

When effects appear: unknown; no source on this page gives a time to effect for Recombinant Human Endostatin. Results reported in the studies are under Published Research.

Source: Used in human trials, the duration of each row in Dosing Data below.

Side effects, and when to stop or get help

From the Side Effects section: Severe neutropenia, anaemia and nausea occurred at similar rates with Endostar and with placebo added to chemotherapy in the phase 3 trial (PMID 28920215); Heart rhythm problems: in the phase 1 continuous-infusion study two patients stopped for ventricular rhythm changes, and ST and T wave ECG changes were the main ECG findings (PMID 25572362); Continuous infusion carried less bone-marrow suppression and heart toxicity than intermittent infusion in a pooled analysis (PMID 33087103); Grade 3 or worse side effects, mostly low white cell counts, affected 58% of patients when it was combined with chemoradiotherapy (PMID 30773184); No bleeding or clotting problems were seen in a nasopharyngeal cancer trial (PMID 32035692). Full list and cautions ↓

When to stop or get help: unknown; no label or trial on file sets rules for stopping Recombinant Human Endostatin. Treat a severe or unexpected reaction as a reason to stop and see a doctor.

Source: the Side Effects section below (“Rh-endostatin is always given with other cancer treatment, so most side effects in these trials come from the combination”).

Interactions

Unknown: a PubMed search for human interaction studies of Recombinant Human Endostatin (reviewed 2026-10-28) found none. Unknown is not the same as safe to combine.

Every peptide's record, with its source: the interaction matrix.

Checking what you bought

Unknown: no published independent test of Recombinant Human Endostatin products is in our lab-results database yet, so how products sold under this name measure up is not known.

To read a certificate of analysis, paste it into the COA decoder. Trust & Verification explains what independent testing can and cannot show.

Legal status

US: Not FDA Approved (Approved by China's State Food and Drug Administration in September 2005 for non-small-cell lung cancer, as reported in peer-reviewed papers (PMIDs 32700135, 17644065). Sport: Unsettled (S0 may apply).

Country by country ↓ · Regulatory tracker

Source: this entry's approval status and the WADA Prohibited List, as in Legal Status below.

Safety

Side Effects & Contraindications

Reported Side Effects

Rh-endostatin is always given with other cancer treatment, so most side effects in these trials come from the combination. These are the ones the abstracts single out.

● Severe neutropenia, anaemia and nausea occurred at similar rates with Endostar and with placebo added to chemotherapy in the phase 3 trial (PMID 28920215)
● Heart rhythm problems: in the phase 1 continuous-infusion study two patients stopped for ventricular rhythm changes, and ST and T wave ECG changes were the main ECG findings (PMID 25572362)
● Continuous infusion carried less bone-marrow suppression and heart toxicity than intermittent infusion in a pooled analysis (PMID 33087103)
● Grade 3 or worse side effects, mostly low white cell counts, affected 58% of patients when it was combined with chemoradiotherapy (PMID 30773184)
● No bleeding or clotting problems were seen in a nasopharyngeal cancer trial (PMID 32035692)

Contraindications & Cautions

There is no US or EU label. Trials excluded patients according to their own protocols, which the abstracts do not detail.

● It is a hospital cancer drug given with chemotherapy or radiotherapy, never on its own outside a trial
● Heart rhythm changes were the dose-limiting effect in the phase 1 study, so ECG monitoring was part of trial care (PMID 25572362)
Questions

Frequently Asked Questions

?What is rh-endostatin?

A recombinant form of endostatin, the body's own blood-vessel-blocking fragment of collagen XVIII, made in E. coli with nine extra amino acids that make it soluble and stable. It is sold in China as Endostar.

?Where is it approved?

In China, since 2005, for advanced non-small-cell lung cancer given with chemotherapy. It is not approved in the US or the EU.

?What dose is used?

Most trials gave 7.5 mg per square metre of body surface once a day for 14 days of each 3-week chemotherapy cycle, or the same amount per 24 hours as a continuous infusion. These are trial schedules given in hospital, not recommendations.

?Does it work?

In the Chinese phase 3 lung cancer trial it raised the response rate and time to progression when added to chemotherapy, and many later trials were positive. But it did not help in extensive small-cell lung cancer, and most of the evidence comes from small open-label trials in China.

?What are the main side effects?

In combination trials, side effects were mostly those of the chemotherapy. Heart rhythm and ECG changes were the dose-limiting effect in a phase 1 study, and continuous infusion appeared to cause fewer heart and blood-count problems than daily infusion.

?Is it the same as natural endostatin?

No. It is a manufactured version with an added nine-amino-acid sequence, made so the protein stays soluble and stable as a drug.

Bibliography

References

  1. [pubmed] Ling Y, et al. "Endostar, a novel recombinant human endostatin, exerts antiangiogenic effect via blocking VEGF-induced tyrosine phosphorylation of KDR/Flk-1 of endothelial cells." Biochem Biophys Res Commun, 2007;361(1):79-84. PMID: 17644065.
  2. [pubmed] Wu H, et al. "The inhibitory effects of rh-endostatin (YH-16) in combination with radiotherapy on lung adenocarcinoma A549 in mice and the underlying mechanisms." J Huazhong Univ Sci Technolog Med Sci, 2010;30(1):108-12. PMID: 20155466.
  3. [clinical-trial] Shi H, et al. "[Phase II clinical trial of homemade human rh-endostatin in the treatment of patients with stage IIIB-IV non-small cell lung cancer]." Zhongguo Fei Ai Za Zhi, 2004;7(4):325-8. PMID: 21241552.
  4. [clinical-trial] Yang L, et al. "[Randomized phase II trial on escalated doses of Rh-endostatin (YH-16) for advanced non-small cell lung cancer]." Zhonghua Zhong Liu Za Zhi, 2006;28(2):138-41. PMID: 16750022.
  5. [clinical-trial] Wang J, et al. "[Results of randomized, multicenter, double-blind phase III trial of rh-endostatin (YH-16) in treatment of advanced non-small cell lung cancer patients]." Zhongguo Fei Ai Za Zhi, 2005;8(4):283-90. PMID: 21108883.
  6. [clinical-trial] Sun Y, et al. "Long-term results of a randomized, double-blind, and placebo-controlled phase III trial: Endostar (rh-endostatin) versus placebo in combination with vinorelbine and cisplatin in advanced non-small cell lung cancer." Thorac Cancer, 2013;4(4):440-448. PMID: 28920215.
  7. [clinical-trial] Lu S, et al. "A multicenter, open-label, randomized phase II controlled study of rh-endostatin (Endostar) in combination with chemotherapy in previously untreated extensive-stage small-cell lung cancer." J Thorac Oncol, 2015;10(1):206-11. PMID: 25654728.
  8. [clinical-trial] Chen J, et al. "A randomized Phase III trial of neoadjuvant recombinant human endostatin, docetaxel and epirubicin as first-line therapy for patients with breast cancer (CBCRT01)." Int J Cancer, 2018;142(10):2130-2138. PMID: 29238974.
  9. [clinical-trial] Chen J, et al. "Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective, randomized, phase II study." BMC Cancer, 2013;13:248. PMID: 23693018.
  10. [clinical-trial] Zhang X, et al. "A Randomized Parallel Controlled Phase II Trial of Recombinant Human Endostatin Added to Neoadjuvant Chemotherapy for Stage III Breast Cancer." Clin Breast Cancer, 2020;20(4):291-299.e3. PMID: 32482525.
  11. [clinical-trial] Chen Z, et al. "Endostar in combination with modified FOLFOX6 as an initial therapy in advanced colorectal cancer patients: a phase I clinical trial." Cancer Chemother Pharmacol, 2015;75(3):547-57. PMID: 25572362.
  12. [clinical-trial] Bao Y, et al. "Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer." Radiother Oncol, 2015;114(2):161-6. PMID: 25497558.
  13. [clinical-trial] Zhai Y, et al. "HELPER study: A phase II trial of continuous infusion of endostar combined with concurrent etoposide plus cisplatin and radiotherapy for treatment of unresectable stage III non-small-cell lung cancer." Radiother Oncol, 2019;131:27-34. PMID: 30773184.
  14. [clinical-trial] Honglian M, et al. "Different administration routes of recombinant human endostatin combined with concurrent chemoradiotherapy might lead to different efficacy and safety profile in unresectable stage III non-small cell lung cancer: Updated follow-up results from two phase II trials." Thorac Cancer, 2020;11(4):898-906. PMID: 32068962.
  15. [pubmed] Zhu J, et al. "Efficacy and safety of recombinant human endostatin during peri-radiotherapy period in advanced non-small-cell lung cancer." Future Oncol, 2022;18(9):1077-1087. PMID: 34986655.
  16. [pubmed] Chen L, et al. "Efficacy and safety of recombinant human endostatin combined with whole-brain radiation therapy in patients with brain metastases from non-small cell lung cancer." Radiother Oncol, 2022;174:44-51. PMID: 35788355.
  17. [pubmed] Chen G, et al. "Efficacy and safety of Rh-endostatin in the treatment of radiation pneumonitis in non-small cell lung cancer." Oncologist, 2025;30(11). PMID: 41014160.
  18. [clinical-trial] Hu Z, et al. "Rh-Endostatin Plus Irinotecan/Cisplatin as Second-Line Therapy for Advanced Esophageal Squamous Cell Carcinoma: An Open-Label, Phase II Study." Oncologist, 2022;27(4):253-e312. PMID: 35380726.
  19. [clinical-trial] Lu H, et al. "Endostar, an Antiangiogenesis Inhibitor, Combined With Chemoradiotherapy for Locally Advanced Cervical Cancer." Oncol Res, 2022;28(9):929-944. PMID: 34544526.
  20. [clinical-trial] Li Y, et al. "A phase II multicenter randomized controlled trial to compare standard chemoradiation with or without recombinant human endostatin injection (Endostar) therapy for the treatment of locally advanced nasopharyngeal carcinoma: Long-term outcomes update." Curr Probl Cancer, 2020;44(1):100492. PMID: 32035692.
  21. [clinical-trial] Dong C, et al. "First-line envafolimab plus recombinant human-endostatin in advanced non-small cell lung cancer with PD-L1 tumor proportion score ≥1% (Endouble): A multicenter, prospective, single-arm, phase 2 trial." Cancer, 2026;132(11):e70479. PMID: 42216493.
  22. [review] An J, et al. "Endostar (rh-endostatin) versus placebo in combination with vinorelbine plus cisplatin chemotherapy regimen in treatment of advanced non-small cell lung cancer: A meta-analysis." Thorac Cancer, 2018;9(5):606-612. PMID: 29575575.
  23. [review] Rong B, et al. "Systematic review and meta-analysis of Endostar (rh-endostatin) combined with chemotherapy versus chemotherapy alone for treating advanced non-small cell lung cancer." World J Surg Oncol, 2012;10:170. PMID: 22917490.
  24. [review] Yuan M, et al. "Endostar (rh-endostatin) improves efficacy of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer: A systematic review and meta-analysis." Thorac Cancer, 2021;12(23):3208-3215. PMID: 34676669.
  25. [review] Biaoxue R, et al. "Thoracic perfusion of recombinant human endostatin (Endostar) combined with chemotherapeutic agents versus chemotherapeutic agents alone for treating malignant pleural effusions: a systematic evaluation and meta-analysis." BMC Cancer, 2016;16(1):888. PMID: 27842514.
  26. [review] Wang B, et al. "Endostar continuous versus intermittent intravenous infusion combined with chemotherapy for advanced NSCLC: a systematic review and meta-analysis including non-randomized studies." BMC Cancer, 2020;20(1):1021. PMID: 33087103.
  27. [review] Li K, et al. "Current Status and Study Progress of Recombinant Human Endostatin in Cancer Treatment." Oncol Ther, 2018;6(1):21-43. PMID: 32700135.
  28. [review] Anakha J, et al. "Recombinant human endostatin as a potential anti-angiogenic agent: therapeutic perspective and current status." Med Oncol, 2023;41(1):24. PMID: 38123873.
  29. [other] US FDA, Drugs@FDA (openFDA): no application for endostatin. Read October 28, 2026.

Sources & Citations

Every study on this page was read from its PubMed record on October 28, 2026. US and EU status come from Drugs@FDA (openFDA) and the EMA medicines list, read the same day; the Chinese approval is as reported in the cited papers. Grey Peptides sells nothing and links to no vendor.

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Last reviewed: 2026-10-28