RecruitingPhase 2NCT06543069

Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM

A Single-Arm, Phase II Clinical Study of Sintilimab and Bevacizumab Combined With Pemetrexed and Cisplatin for Unresectable Malignant Peritoneal Mesothelioma


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

28 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To explore the efficacy and safety of sintilimab, bevacizumab combined with pemetrexed and cisplatin in the treatment of malignant peritoneal mesothelioma, and to explore the biomarkers related to efficacy or safety.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of four drugs — sintilimab (an immunotherapy), bevacizumab (a drug that blocks tumor blood supply), pemetrexed, and cisplatin (chemotherapy) — for people with peritoneal mesothelioma, a rare cancer lining the abdomen that cannot be removed by surgery. **You may be eligible if...** - You are 18 or older and have been confirmed to have peritoneal mesothelioma - Your cancer cannot be removed surgically - You are in good physical condition (ECOG 0–1) - You have reasonable organ function (blood counts, liver, kidney) - Your expected survival is at least 3 months - Women of childbearing potential must test negative for pregnancy **You may NOT be eligible if...** - You have active autoimmune disease or are taking immune-suppressing drugs - You have uncontrolled infections, heart problems, or other serious conditions - You have had prior chemotherapy for this cancer - You have brain metastases 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

DRUGSintilimab, Bevacizumab , Pemetrexed , Cisplatin

Sintilimab: 200mg, bevacizumab: 7.5mg/kg, pemetrexed: 500mg/m2, cisplatin: 75mg /m2, Q3w. Tumor assessments will be performed every two cycles according to RECIST 1.1 criteria. After 6 cycles, maintenance therapy with sintilimab, bevacizumab, and pemetrexed will continue until disease progression or unacceptable toxicity occurs.


Locations(1)

Cancer Institute and Hospital,Chinese Academy of Medical Sciences

Beijing, China

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NCT06543069


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