Malignant pleural mesothelioma
Conditions
Interventions
Experimental group:Cadonilimab 10mg/Kg+ pemetrexed + platinum
Or: Cadonilimab 10mg/Kg+ chemotherapy regimen determined by investigator
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, =80g/L, neutrophil absolute count (ANC) >=1.5×10^9/L, platelet count (PLT) >=80×10^9/L; Liver function: Serum total bilirubin (TBIL) =28 g/L; Renal function: serum creatinine (Cr) =45mL/min. 8. Both men and women of reproductive age should agree and use effective contraception until 30 days after the last dose of cardonili, and male subjects should refrain from sperm donation.
Exclusion criteria
Exclusion criteria: 1. Participants with other malignant tumors within 3 years, except those with skin basal cell carcinoma, squamous cell carcinoma or cervical carcinoma in situ and other well-controlled conditions; 2. Received major surgery or severe trauma within 4 weeks prior to enrollment; 3. Known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, lupus erythematosus, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, etc. Participants were admitted to the study if they had type 1 diabetes, hypothyroidism requiring hormone replacement therapy alone, skin conditions that did not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or conditions that were not expected to recur in the absence of external triggers. 4. The subject has a disease that requires continued long-term treatment with systemic glucocorticoids (>10mg/ day equivalent conversion dose of prednisone) or other immunosuppressive drugs. Participants who were treated with topical, ocular, intra-articular, intranasal, inhalation, and adrenal replacement steroids were admitted without active immune disease. 5. Grade III-IV congestive heart failure (New York Heart Association rating), persistent symptomatic arrhythmias, uncontrolled atrial fibrillation; Multiple echocardiographic assessments of left ventricular ejection fraction (LVEF) were below the lower limit of normal. Uncontrolled arterial hypertension (systolic =160mmHg or diastolic =100mmHg); 6. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction and instability, occurred in the 6 months prior to treatment typical angina pectoris, cerebrovascular accident or transient ischemic attack, except arterial mural thrombosis; 7. Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Have other uncontrolled serious diseases, including but not limited to: active or clinically poorly controlled serious infections; HIV infected persons (HIV antibody positive); Have acute or chronic active hepatitis B (except HBsAg positive participants with HBV DNA 15IU/ml); Active pulmonary tuberculosis; 9. Participants who had previously used PD-1/PD-L1 antibody and CTLA-4 antibody for tumor progression, such as participants who stopped taking PD-1/PD-L1 antibody and CTLA-4 antibody after double-drug immunotherapy due to adverse reactions or participants who stopped taking the drug on their own, could participate in this study; 10. Pregnant or lactating women; 11. The researcher judged that it was not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Duration of response;Overall survival; | — |
Countries
China
Contacts
Public ContactYanying Li
West China Hospital of Sichuan University
Outcome results
None listed