Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM
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.
| Condition(s) | Malignant Peritoneal Mesothelioma, Advanced |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Fully understand the study and voluntarily sign the informed consent form; 2. Age ≥18 years old; 3. Pathologically (including histologically or cytologically) confirmed as peritoneal mesothelioma; 4. ECOG performance status of 0-1; 5. Expected survival of ≥3 months; 6. 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); 7. Women of childbearing potential must have a negative serum pregnancy tes |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Locations | Beijing, China |
| Start date | 2024-01-31 |
| NCT ID | NCT06543069 |
| Official listing | https://clinicaltrials.gov/study/NCT06543069 |