Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06543069
Phase
PHASE2
Status
Recruiting
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Conditions

  • Malignant Peritoneal Mesothelioma, Advanced

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sintilimab, Bevacizumab , Pemetrexed , Cisplatin — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 7, 2024
Start date
Jan 31, 2024
Status verified
Aug 2024
Primary completion
Jan 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single arm
    Sintilimab and Bevacizumab Combined with Pemetrexed and Cisplatin

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 36 months ]

Central Contacts

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