Endostar
Also known as: Endostar injection, Recombinant Human Endostatin, rh-Endostatin, YH-16
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Summary
Endostar is a recombinant form of human endostatin, an endogenous protein that blocks new blood‑vessel formation. It is approved for prescription use and administered by injection. Clinical research has explored its use mainly as an adjunct to chemotherapy or trans‑arterial chemoembolisation in cancers such as non‑small‑cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC), and it has been mentioned as a potential vascular‑targeted scar therapy.
Mechanism of Action
Endostar mimics endostatin, a natural inhibitor of angiogenesis. It binds to endothelial cells and interferes with vascular endothelial growth factor (VEGF) signaling pathways, suppressing endothelial proliferation, migration and tube formation. By curtailing micro‑vessel growth, it reduces tumour‑derived blood supply and may also limit the hypervascular response that contributes to hypertrophic scar formation.
What the Research Shows
Systematic reviews and meta‑analyses of randomised trials report that adding Endostar to platinum‑based chemotherapy improves overall response and disease‑control rates in advanced NSCLC, with modest gains in time to progression and quality of life. In HCC, combining Endostar with trans‑arterial chemoembolisation increased 6‑ and 12‑month survival and response rates without raising adverse‑event rates. A separate review noted disappointing results for Endostar in small‑cell lung cancer when paired with chemotherapy. Pre‑clinical discussion suggests a role in vascular‑dominant scar management, but clinical scar data are lacking. Evidence for optimal infusion schedule (continuous vs intermittent) remains low‑quality and requires larger trials.
Reported Benefits
Evidence from multiple meta‑analyses indicates that Endostar can raise response and disease‑control rates in NSCLC and improve short‑term survival outcomes when combined with TACE in HCC. Some low‑quality data suggest a survival advantage with continuous intravenous infusion versus intermittent dosing in NSCLC, and a reduced risk of myelosuppression and cardiovascular toxicity. Overall, Endostar appears to enhance the efficacy of standard therapies without markedly increasing common chemotherapy‑related side effects.
Limitations of the Evidence
The majority of data come from small or heterogeneous trials; many meta‑analyses note the need for larger, high‑quality randomised studies. In HCC, only nine trials with 411 participants were analysed, limiting confidence in long‑term benefits. The survival advantage of continuous infusion in NSCLC is supported by very low‑quality evidence. Endostar showed little benefit in small‑cell lung cancer, and its proposed use for hypertrophic scar treatment remains theoretical, lacking clinical trial confirmation.
Safety Considerations
Clinical trials report adverse events similar to chemotherapy alone, including leukocytopenia, hepatic enzyme elevations, nausea, vomiting and general myelosuppression. Hematologic reactions, hepatic toxicity, and nausea/vomiting were the most frequently noted. Continuous intravenous infusion may lower the incidence of myelosuppression and cardiovascular toxicity compared with intermittent infusion. No new safety signals have emerged, but clinicians should monitor blood counts and liver function during therapy.
How It Is Administered
Endostar is supplied for injection and can be given intravenously (either as a continuous or intermittent infusion) or subcutaneously. In cancer studies it is typically administered in combination with standard chemotherapy regimens or with trans‑arterial chemoembolisation procedures.
Routes of Administration
Goals & Uses
- Nasopharyngeal carcinomaOncologyLow
- Non-small cell lung cancer (NSCLC) treatmentOncologyHigh
- Hepatocellular carcinomaOncologyModerate
- Tumor angiogenesis inhibitionOncology / AntiangiogenicHigh
- Non‑small cell lung cancerOncologyHigh
- Colorectal cancerOncologyModerate
- Malignant pleural effusionOncologyModerate
Contraindications
- Serious hypersensitivity to recombinant proteinsAllergy/ImmunologyHigh
- Severe hepatic impairmentOrganModerateLiver function concerns
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Severe cardiac dysfunctionCardiovascularHigh
Adverse Effects
- ProteinuriaRenalUncommon
- HypertensionCardiovascularCommonHigh blood pressure
- Nausea/vomitingGastrointestinalCommon
- NeutropeniaHematologicUncommonLow neutrophil count
- FatigueGeneralCommonLow energy or tiredness
- Cardiovascular events (arrhythmia, chest discomfort)CardiovascularUncommon
- Elevated liver enzymesHepaticUncommonIncrease in AST/ALT or other hepatic markers
- Infusion-related reactionsHypersensitivityUncommon
Drug Interactions
- Anticoagulants (e.g., warfarin)Moderate
- Vinorelbine/Cisplatin (NP regimen)Low
- Anticoagulants (warfarin, heparin)Moderate
- other anti‑angiogenic agents (e.g., bevacizumab)Moderate
Population Constraints
- Pediatric patientsAgeRelative
- Patients with hepatic impairmentOrgan FunctionRelative
- Elderly patients (>70 years)AgeRelative
- Lactating womenReproductiveAbsolute
- Elderly (>75 years)GeriatricRelative
Regulatory Status
- CNApprovedApproved: non‑small cell lung cancerApproved by NMPA (2015).
- European UnionUnapprovedNo EMA marketing authorization.
- United StatesUnapprovedInvestigational; not FDA‑approved.
- United KingdomUnapprovedNot approved by MHRA in the United Kingdom.
Approved by the National Medical Products Administration (NMPA, China) for NSCLC; not approved by FDA or EMA.
Evidence & Sources
- Journal ArticleModerateYuan B, et al.2023-01-01T00:00:00.000000Z
- Journal ArticleModerateLi S, et al.2023-01-01T00:00:00.000000Z
- Journal ArticleHighZhang YQ, et al.2017-01-01T00:00:00.000000Z
- Journal ArticleHighRong B, et al.2012-01-01T00:00:00.000000Z
- Journal ArticleHighWang B, et al.2020-01-01T00:00:00.000000Z
- Journal ArticleModerateMontanino A, et al.2021-01-01T00:00:00.000000Z
Frequently Asked Questions
What types of cancer have been studied with Endostar?
Randomised trials have evaluated Endostar combined with chemotherapy in advanced non‑small‑cell lung cancer and with trans‑arterial chemoembolisation in hepatocellular carcinoma. Small‑cell lung cancer studies have shown limited benefit.
Does Endostar increase the risk of side effects compared with chemotherapy alone?
Meta‑analyses report that overall adverse‑event rates (including leukocytopenia, liver enzyme changes, nausea and vomiting) are similar to chemotherapy alone. Continuous infusion may even reduce myelosuppression and cardiovascular toxicity.
Is there evidence that Endostar improves overall survival?
In hepatocellular carcinoma, combined treatment improved 6‑ and 12‑month survival rates. In non‑small‑cell lung cancer, very low‑quality evidence suggests a survival benefit with continuous infusion, but larger trials are needed to confirm.
Can Endostar be used for scar treatment?
Endostar has been mentioned as a vascular‑targeted option for hypertrophic scar management, based on its anti‑angiogenic properties, but no clinical trials have yet validated its efficacy for this indication.
What are the recommended routes of administration?
Endostar is administered by injection, either intravenously (continuous or intermittent infusion) or subcutaneously, usually in combination with other anticancer therapies.
What is Endostar?
Endostar is a recombinant form of human endostatin, an endogenous protein that blocks new blood‑vessel formation. It is approved for prescription use and administered by injection. Clinical research has explored its use mainly as an adjunct to chemotherapy or trans‑arterial chemoembolisation in cancers such as non‑small‑cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC), and it has been mentioned as a potential vascular‑targeted scar therapy.
What is Endostar used for?
Endostar is educationally associated with: Nasopharyngeal carcinoma, Non-small cell lung cancer (NSCLC) treatment, Hepatocellular carcinoma, Tumor angiogenesis inhibition, Non‑small cell lung cancer, Colorectal cancer, Malignant pleural effusion. Educational only — not medical advice.
How is Endostar administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Endostar?
Reported adverse effects include: Proteinuria, Hypertension, Nausea/vomiting, Neutropenia, Fatigue, Cardiovascular events (arrhythmia, chest discomfort), Elevated liver enzymes, Infusion-related reactions. This list is not exhaustive — consult a qualified clinician.
Who should avoid Endostar?
Recorded contraindications: Serious hypersensitivity to recombinant proteins, Severe hepatic impairment, Pregnancy, Severe cardiac dysfunction. Consult a qualified clinician before use.