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.
This single-arm study aims to enroll 28 patients with unresectable malignant peritoneal mesothelioma. Enrolled patients will undergo treatment with sintilimab (200 mg), bevacizumab (7.5 mg/kg), pemetrexed (500 mg/m\^2), and cisplatin (75 mg/m\^2) administered every three weeks. Tumor assessments will be performed every two cycles according to RECIST 1.1 criteria, and after six cycles, maintenance therapy with sintilimab, bevacizumab, and pemetrexed will continue until disease progression or unacceptable toxicity occurs. The primary outcome measure of the study is Progression-Free Survival (PFS), while secondary outcomes include Overall Survival (OS), Objective Response Rate (ORR), and Disease Control Rate (DCR).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
Cancer Institute and Hospital,Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGProgression-Free Survival (PFS)
The time from the date of first administration of this regimen to the date of first documented disease progression or death due to any cause.
Time frame: 36 months
Overall Survival (OS)
The time from the initiation of the first dose of medication in a patient to death from any cause.
Time frame: 36 months
Objective Response Rate (ORR)
The proportion of patients with a comfirmed complete response or patial response using RECIST1.1.
Time frame: 36 months
Disease Control Rate (DCR)
The percentage of patients who have achieved complete response, partial response, and stable disease to the treatment, as defined by RECIST 1.1 criteria.
Time frame: 36 months
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