OncoMatch/Clinical Trials/NCT05188859
First Line Sintilimab Combined With Anlotinib and Platinum Doublet Chemotherapy in Malignant Pleural Mesothelioma
Is NCT05188859 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sintilimab+Anlotinib+Pemetrexed+Cisplatin for mesothelioma, malignant.
Treatment: Sintilimab+Anlotinib+Pemetrexed+Cisplatin — This study is a single-arm, open-lable, single-center phase II clinical trial for patients with advanced or metastatic pleural mesothelioma. The aim of this study was to observe and evaluate the efficacy and safety of Sintilimab combined with Anlotinib hydrochloride and platinum-containing dual-agent chemotherapy as first-line therapy in malignant pleural mesothelioma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Mesothelioma
Disease stage
Required: Stage IIIB, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Previous usage of the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug
Lab requirements
Blood counts
ANC ≥ 1.5x10^9/L (no G-CSF in past 14 days); platelets ≥ 100x10^9/L (no transfusion in past 14 days); hemoglobin > 9g/dL (no transfusion or erythropoietin in past 14 days)
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance (Cockcroft-Gault) ≥ 60ml
Liver function
Total bilirubin ≤ 1.5 × ULN (if total bilirubin > 1.5 × ULN but direct bilirubin ≤ ULN is also allowed); AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN with liver metastasis)
Cardiac function
Myocardial enzyme spectrum within normal range (if no clinical significance of simple lab abnormalities, can be included)
For adequate organ function, the patients need to meet the following laboratory indexes: 1. the absolute value of neutrophils (ANC) ≥ 1.5x109/L without granulocyte colony stimulating factor in the past 14 days. 2. in the last 14 days without blood transfusion, the platelet count was ≥ 100x109/L. 3. in the absence of blood transfusion or the use of erythropoietin in the past 14 days, hemoglobin > 9g/dL; 4. Total bilirubin ≤ 1.5 × ULN; for example,if total bilirubin > 1.5 × ULN but direct bilirubin ≤ ULN is also allowed to enter the group 5. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (patients with liver metastasis allow ALT or AST ≤ 5 × ULN). 6. Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60ml; 7. Coagulation function is good, defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8. Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled. 9. Myocardial enzyme spectrum is within the normal range (if the researchers comprehensively judge that there is no clinical significance of simple laboratory abnormalities can also be included in the group); (optional)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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