A Single-Arm, Phase II Clinical Study of Sintilimab and Bevacizumab Combined With Pemetrexed and Cisplatin for Unresectable Malignant Peritoneal Mesothelioma
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.
• Fully understand the study and voluntarily sign the informed consent form;
• Age ≥18 years old;
• Pathologically (including histologically or cytologically) confirmed as peritoneal mesothelioma;
• ECOG performance status of 0-1;
• Expected survival of ≥3 months;
• Function of vital organs must meet the following criteria (use of any blood products and cell growth factors is not allowed within 14 days prior to enrollment): Absolute neutrophil count ≥1.5×10\^9/L; Platelets ≥100×10\^9/L; Hemoglobin ≥90g/L; Total bilirubin \<1.5 times the upper limit of normal (ULN); ALT and AST \<2.5×ULN, GPT ≤1.5×ULN; Serum creatinine ≤1×ULN; Creatinine clearance rate \>60 ml/min (Cockcroft-Gault formula);
• Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last dose of trial medication; for men, must be surgically sterilized or agree to use appropriate contraception during the trial and for 8 weeks after the last dose of trial medication;
• Have not participated in other clinical studies within 4 weeks before enrollment and during treatment. -