malignant mesothelioma
Conditions
Interventions
treatment group:camrelizumab combination apatinib mesylate
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. ECOG 0-1 score; 3. Malignant mesothelioma with histological or cytological evidence cannot be surgically resected; 4. Progression after first-line or second-line chemotherapy containing pemetrexed plus platinum 5. Normal function of major organs; 6. Expected survival of not less than 12 weeks; 7. Women of childbearing age must have been using reliable contraception or had a pregnancy test (serum or urine) within 7 days prior to enrol, with a negative result, and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the test drug. For men, consent to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last dose of the trial drug; 8. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up; 9. Adequate organ function, as defined below: 9.1) Blood system (in the absence of blood transfusion, granulocyte colony-stimulating factor, or other medical support within 14 days prior to initiation of investigational drug therapy) : a) ANC = 1.5 ×10^9/L; b) PLT = 100 ×10^9/L; c) Hb = 90 g/L; 8.2) Liver function: a) TBIL = 1.5 ×ULN, liver metastasis subjects = 2 ×ULN; b) AST and ALT = 2.5 × ULN (liver metastasis subjects can = 5 × ULN); c) ALP = 2.5 × ULN (ALP = 5 × ULN for bone metastasis subjects); 8.3) Kidney function: a) Serum creatinine = 1.5 × ULN or creatinine clearance = 50 ml/min and = 125 ml/min; b) Qualitative urine protein = 1+; If the qualitative urine protein = 2+, 24 h urine protein quantitative examination is required, if the quantitative urine protein < 1 g in 24 h, it is acceptable. 8.4) Coagulation function: INR, APTT = 1.5 × ULN; Subjects with liver metastasis should = 2 × ULN
Exclusion criteria
Exclusion criteria: 1. Imaging (CT or MRI) shows that the tumor lesion is less than 5mm away from the major blood vessels, or there is a central tumor that has invaded the local major blood vessels; Or the presence of significant pulmonary cavity or necrotic tumor; 2. Daily hemoptysis of 2 teaspoons or more before enrollment; 3. Clinically significant bleeding symptoms or definite bleeding tendency occurred within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic hemorrhoids, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline, or vasculitis; 4. Receive the last radiotherapy or antitumor therapy within 3 weeks before the first dose; Received non-specific immunomodulatory therapy within two weeks prior to initial administration; Received any herbal or proprietary Chinese medicine with anti-tumor indications within 7 days prior to initial administration; 5. Prior receipt of any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or any other antibody or drug therapy targeting T cell co-stimulation or checkpoint pathways, such as ICOS or agonists (such as CD40, CD137, GITR, OX40, etc.); 6. There are active central nervous system (CNS) metastases, meningeal metastasis, spinal cord compression, and pia meningeal diseases; 7. Known to have interstitial lung disease; Or have a history of non-infectious pneumonia requiring oral or intravenous glucocorticoid therapy; 8. Has an active autoimmune disease requiring systemic treatment, or has a history of autoimmune disease; 9. Subjects requiring systemic treatment with corticosteroids (>10mg/ day equivalent dose of prednisone) or other immunosuppressive agents within 14 days prior to initial dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR; | — |
Countries
China
Contacts
Public ContactHongyang Lu
Zhejiang Cancer Hospital
Outcome results
None listed