RecruitingPhase 2NCT04812002

Study of PD-1 Antibody and Bevacizumab in the Treatment of High-risk GTN After Combined Chemotherapy

Phase II Single-arm Clinical Study of PD-1 Antibody and Bevacizumab in the Treatment of Relapsed or Refractory High-risk Gestational Trophoblasitc Neoplasia After Second-line or Above Combined Chemotherapy


Sponsor

Women's Hospital School Of Medicine Zhejiang University

Enrollment

20 participants

Start Date

Apr 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Gestational trophoblastic Neoplasia(GTN) is a kind of malignant tumor in women of childbearing age. It is easy to metastasized through the blood system in the early stage, so it is a relatively malignant tumor. The tumor is highly sensitive to chemotherapy, and low-risk patients have good prognosis, with survival rate and cure rate approaching 100%, but high-risk patients are prone to drug resistance, or relapse after remission. For relapsed, refractory, high-risk GTN, multiple remedies have been reported in the literature, but the remission rate is only 75-80%. For relapsed or refractory high-risk GTN, multiple remedies have been reported in the literature, but the remission rate is only 75-80%. Currently, targeted therapy and immunotherapy are widely used in various refractory solid tumors. For GTN, there are also a number of related studies. In this study, PD-1 inhibitors combined with bevacizumab were used to treat refractory high-risk GTN with relapse or drug resistance after receiving previous second-line or above multidrug combination therapy, to study the efficacy and safety of the treatment regimen.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining an immunotherapy drug (PD-1 antibody) with bevacizumab (a drug that blocks tumor blood vessel growth) can help people with gestational trophoblastic neoplasia (GTN) — a rare cancer that develops from pregnancy tissue — whose cancer has returned or become resistant to multiple chemotherapy regimens. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with recurrent or drug-resistant gestational trophoblastic neoplasia (a rare pregnancy-related cancer) - You have already received at least two different multi-drug chemotherapy regimens that stopped working - You are in reasonably good health (Karnofsky ≥ 60, ECOG ≤ 2) **You may NOT be eligible if...** - You are pregnant - You have active serious infections - You have severe heart, liver, or kidney problems - Your expected survival is less than 3 months 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPD-1 inhibitor, bevacizumab

Both drugs are given intravenously


Locations(1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04812002


Related Trials