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First-line Treatment With Dual Immunotherapy Combined With Anti-angiogenesis for Unresectable Advanced Malignant Peritoneal Mesothelioma
Sponsor: Fudan University
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
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.
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.
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