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NOT YET RECRUITING
NCT07893340
PHASE2

First-line Treatment With Dual Immunotherapy Combined With Anti-angiogenesis for Unresectable Advanced Malignant Peritoneal Mesothelioma

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, single-arm, Phase II clinical study evaluating the efficacy and safety of sintilimab in combination with ipilimumab N01 and bevacizumab as first-line treatment in patients with unresectable malignant peritoneal mesothelioma. Eligible patients will receive sintilimab plus ipilimumab N01 and bevacizumab until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons, with a maximum treatment duration of 24 months. The primary endpoint is progression-free survival (PFS).

Official title: Sintilimab Combined With Ipilimumab N01 and Bevacizumab for First-line Treatment of Unresectable Malignant Peritoneal Mesothelioma: a Single-arm, Phase II Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2026-10-30

Completion Date

2030-09-30

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DRUG

Sintilimab

Sintilimab: 200 mg IV, D1 and D22, Q3W (Day 1 of every 3 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

DRUG

Ipilimumab N01

Ipilimumab N01: 1 mg/kg IV, D1, Q6W (Day 1 of every 6 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

DRUG

Bevacizumab

Bevacizumab: 15 mg/kg IV, D1 and D22, Q3W (Day 1 of every 3 weeks) Treatment continues until disease progression, death, unacceptable toxicity, withdrawal of informed consent, initiation of a new anti-tumor therapy, or other protocol-defined reasons; maximum treatment duration is 24 months.

Locations (1)

Fudan University ShangHai Cancer Center

Shanghai, Shanghai Municipality, China