malignant mesothelioma
Conditions
Interventions
treatment group:Sintilimab plus pemetrexed and cisplatin/carboplatin
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 2. Age 18~80 years old; 3. Malignant pleural mesothelioma with histological or cytological confirmation that cannot be surgically resected or newly treated; 4. According to the mRECIST (Response Evaluation Criteria in Solid Tumors) criteria, at least one measurable lesion on imaging, defined as: mesothelioma tumor thickness perpendicular to the chest wall or mediastinal cavity, which can be measured at up to two locations at three different levels of the computed tomography cross-section (10 mm between sections must be spaced apart), up to a total of 6 lesions. Each tumor measurement must be at least 10 mm in size to be considered measurable disease and can be used to calculate the sum and be defined as a pleural measurement; 5. Prior RT (palliative radiotherapy) is acceptable, but must be at least 14 days apart from the first treatment, and all toxic symptoms must be relieved. Prior pleurodesis drainage port or biopsy site prophylactic RT is permitted; 6. ECOG (Eastern Cooperative Oncology Group) PS (physical condition) score of 0-1; 7. Expected survival time= 3 months; 8. Adequate organ function, subjects need to meet the following laboratory indicators: 1) In the absence of granulocyte colony-stimulating factor in the last 14 days, the absolute neutrophil value (ANC) = 1.5x109/L. 2) In the case of no blood transfusion in the past 14 days, platelet = 100×109/L; 3) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; 4) total bilirubin =1.5× upper limit of normal (ULN); If total bilirubin > 1.5× ULN but direct bilirubin = ULN is also allowed to be enrolled 5) aspartate aminotransferase (AST), alanine aminotransferase (ALT) at = 2.5× ULN (patients with liver metastases are allowed ALT or AST =5×ULN); 6) serum creatinine = 1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) = 60 ml/min; 7) good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; 8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); (Optional) 9. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 10. If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug).
Exclusion criteria
Exclusion criteria: 1. Current participation in interventional clinical study treatment; 2. Previous treatment with the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 (programmed death receptor-2) drugs or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), etc.); 3. Active autoimmune disease requiring systemic therapy (such as use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 4. Brain metastases, except for participants who have had no progression within 3 months prior to surgical resection or stereotactic RT. In addition, participants must be asymptomatic or have discontinued glucocorticoids, or have received a stable or tapered dose of =10 mg of prednisone per day (or equivalent) for at least 2 weeks prior to the first dose of treatment. Imaging studies performed within 28 days prior to randomization must document the radiographic stability of CNS lesions and be performed after completion of any CNS-targeted therapy; 5. Vaccination with a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is allowed within 30 days prior to the first dose; However, intranasal live attenuated influenza vaccine is not permitted. 6. Pregnant or lactating women; 7. Untreated active hepatitis B (untreated active hepatitis B (defined as HBsAg (hepatitis B virus surface antigen) positive and detection of HBV-DNA (hepatitis B DNA) copy number greater than the upper limit of normal in the laboratory department of the research center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: 1) HBV viral load < 1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV therapy throughout the study drug treatment period to avoid viral reactivation; 2) for subjects with anti-HBc ( ), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not require prophylactic anti-HBV therapy, but close monitoring for viral reactivation is required; 8. Presence of any serious or uncontrollable systemic disease, such as: 1) Resting ECG has major abnormalities in rhythm, conduction or morphology and severe symptoms that are difficult to control, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia or atrial fibrillation; 2) unstable angina, congestive heart failure, New York Heart Association (NYHA) classification = grade 2 chronic heart failure; 3) Any arterial thrombosis, embolism or ischemia within 1 month before the selected treatment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, etc.; 4) active tuberculosis; 5) Presence of active or uncontrolled infection requiring systemic therapy; 6) Presence of clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction; 7) Patients with mental disorders who are unable to cooperate with treatment; 9. Abnormal medical history or evidence of disease, treatment or laboratory test values that may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or other conditions that the investigator considers unsuitable for enrollment and other p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival,PFS;Disease control rate,DCR;Overall Survival,OS; | — |
Countries
China
Contacts
Public ContactHongyang Lu
Zhejiang Cancer Hospital
Outcome results
None listed