Renal carcinoma and malignant melanoma
Conditions
Interventions
Advanced renal cell carcinoma group:Camrelizumab combined with sunitinib (1) Camrelizumab (200 mg / time, i.v., D1, q2w or q3w), instillation time 30 minutes to 60 minutes, administered every 2 or 3 w
Malignant melanoma group:Camrelizumab (200 mg / time, i.v., D1, q2w or q3w): fixed dose of 200mg, intravenous infusion administration, drip time 30 minutes to 60 min, administered every 2 weeks or 3 w
Sponsors
Cancer Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients volunteered to join the study, signed the informed consent form, had good compliance and cooperated with follow-up; 2. Patients with stage IV renal cancer or malignant melanoma confirmed by histopathology; 3. The condition for renal cell carcinoma to be enrolled is the patients who have not received anti-tumor drugs for the first time; The conditions for melanoma inclusion are BRAF wild-type patients who have not received the treatment of ICI drugs in the past (can receive targeted treatment or chemotherapy or cytokine treatment). 4. Be willing to provide tumor tissue samples and tissue sections archived or freshly obtained within 12 months before the first drug use for gene detection; 5. Have at least measurable lesions specified in RECIST V1.1 standard (except for only one measurable lymph node lesion); 6. Age: 18-75; 7. ECOG score 0-1; 8. The expected survival period is = 3 months; 9. Subjects should meet the following laboratory examination results, which should be completed within 14 days before the first administration: ? Blood routine examination (no blood transfusion, no use of hematopoietic stimulator drugs within 14 days before screening): ? Hemoglobin (HB) = 90 g/L; ? Platelet count (PLT) = 100 × 109/L ? Absolute value of neutrophil count (ANC) = 1.5 × 109/L Absolute value of lymphocyte count (LC) = 0.5 × 109/L ? White blood cell count (WBC) = 3.0 × 109/L and = 15 × 109/L ? Biochemical examination (no blood or albumin transfusion within 14 days before screening): ? AST and ALT = 2.5 ULN (= 5 ULN if there is tumor liver metastasis) ? ALP = 2.5 ULN (= 5 ULN if there is tumor bone metastasis) ?TBiL=1.5 ULN? ALB=30 g/L ? Cr = 1.5 ULN, and creatinine clearance rate (CrCL) = 60 mL/min (Cockcroft-Gault formula); ? APTT = 1.5 ULN, while INR or PT = 1.5 ULN (without anticoagulation treatment) 3) Thyroid stimulating hormone (TSH) = ULN (if abnormal, the levels of FT3 and FT4 should be investigated at the same time, if the levels of FT3 and FT4 are normal, they can be enrolled); 10. Female patients of non-surgical sterilization or childbearing age need to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study treatment period and within 3 months after the end of the study treatment period; The serum or urine HCG test of female patients of childbearing age who were not surgically sterilized must be negative within 72 hours before study enrollment; And must be non-lactating; For males, surgical sterilization should be performed or appropriate contraception should be used during the trial and within 3 months after the last administration of the test drug.Patients
Exclusion criteria
Exclusion criteria: 1. Patients have any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.); 2. Patients are using immunosuppressive agents, or systemic or absorbable local hormones to achieve immunosuppressive purposes (dose>10mg/day prednisone or other effective hormones), and continue to use them within 2 weeks before enrollment; 3. Severe allergic reaction to other monoclonal antibodies; 4. Patients have clinical symptoms of central nervous system metastasis (such as brain edema, hormone intervention, or brain metastasis progress); 5. Have clinical symptoms or diseases of heart that are not well controlled, such as: (1)Heart failure above NYHA grade 2 (2) Unstable angina pectoris (3)Myocardial infarction occurred within 1 year (4)Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention (5).5 QTc>450ms (male); QTc>470ms (female); 6. Abnormal coagulation function (INR>1.5 or PT>16s), bleeding tendency or undergoing thrombolytic or anticoagulant treatment; 7. Ascites, pleural effusion and pericardial effusion with clinical symptoms that require therapeutic puncture or drainage, such as pleural effusion and pericardial effusion that are stable after drainage to at least 2 weeks before the first application of the first study drug, can be included in the study; 8. Patients have active infection or fever of unknown cause during screening and before the first administration>38.5 ?; 9. Patients with past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other objective evidence; 10. Patients have congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal value; hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value); 11. Those who have used other drugs in clinical trials within 4 weeks before the first administration; 12. The Patient has previously or simultaneously suffered from other malignant tumors (except the cured skin basal cell carcinoma and cervical carcinoma in situ); 13. Patients have previously received other PD-1 antibody treatment or other immunotherapy for PD-1/PD-L1; 14. Live vaccine should be inoculated less than 4 weeks before the study medication or possibly during the study period; 15. According to the judgment of the researcher, the subject has other factors that may lead to the forced termination of the study, such as other serious diseases (including mental illness) requiring combined treatment, serious laboratory examination abnormalities, accompanied by family or social factors, which may affect the safety of the Patient, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective respond rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;disease control rate;progress-free suvival;overall survival; | — |
Countries
china
Contacts
Public ContactDongyuan zhu
Outcome results
None listed