RecruitingPhase 2NCT05193188

A Study of Anlotinib Combined With or Without PD-1 Antibody on Unresectable High-grade Chondrosarcoma

A Multicenter Clinical Controlled Study of Anlotinib Combined With PD-1 Antibody on Unresectable High-grade Chondrosarcoma With Different IDH Genotypes


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

70 participants

Start Date

Feb 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

There is no standard treatment for chondrosarcoma. Some small sample of studies has shown that anti-angiogenic TKIs show certain activity in the treatment of chondrosarcoma. PD-1 inhibitors, in recent years, have also been used in clinical practice and showed good efficacy. We intend to explore the response of chondrosarcoma to PD-1 monoclonal antibody and the influence of different IDH genotypes on PD-1 monoclonal antibody response.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing anlotinib (a targeted anti-cancer drug) with or without a PD-1 immune checkpoint inhibitor in patients with high-grade chondrosarcoma — a rare bone cancer — that cannot be surgically removed and has not been treated with these drug types before. **You may be eligible if...** - You are 18 or older with confirmed high-grade or dedifferentiated chondrosarcoma that is unresectable or has spread - You are in good health (ECOG 0–2) with adequate organ function - You have at least one measurable tumor - You may have had prior surgery, radiation, or chemotherapy **You may NOT be eligible if...** - You have previously received anti-PD-1/PD-L1 immunotherapy - You have previously received anlotinib or similar anti-angiogenic drugs - You have received other anti-cancer therapy within 4 weeks of enrollment - You have uncontrolled high blood pressure, a recent heart attack, or stroke within 6 months - You have significant bleeding risk, active infection, or active liver disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib hydrochloride

Anlotinib 12mg per person per day, continuous medication for 2 weeks and 1 week off, 3 weeks 1 cycle, until disease progression or intolerable toxicity

DRUGPD-1 inhibitor

Intravenous injection, once every 3 weeks, until the disease progression or intolerable toxicity


Locations(1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT05193188


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