Clear Cell Renal Cell Carcinoma
Conditions
Interventions
Single-arm group:Toripalimab combined with pazopanib
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. men and women aged 18 to 75 years old; 2. Histologically confirmed renal cell carcinoma containing clear cell carcinoma components; 3. Simple lung metastases, and the largest diameter of lung metastases is less than 3cm; 4. The primary tumor of the kidney has not received surgical treatment; 5. Have not received any systemic therapy before (including anti-angiogenesis targeted drugs, mTOR inhibitors, cytokines, cytotoxic drugs, immune checkpoint inhibitors); 6. Complete organ function, defined as follows: absolute neutrophil count >=1500 cells/mm3; white blood cell count >=3000 cells/mm3; platelet count >=100,000 cells/mm3; hemoglobin >=9.0 g/dL; AST and ALT =2+, 24-hour urine protein quantification is required, and only those with 24-hour urine protein = 12 weeks; 8. ECOG performance status score of 0 or 1; 9. Two baseline blood pressure measurements (at least 1 hour apart) show the absence of uncontrolled hypertension. Baseline systolic blood pressure must be = 16 weeks after the last study drug treatment administration; 11. The subjects participated voluntarily, signed the informed consent, and were willing to complete the study according to the protocol.
Exclusion criteria
Exclusion criteria: 1. There are contraindications to the drugs involved in the research, including those who are known or suspected to be allergic to the drugs involved in the research; 2. Simultaneous application of other systemic anti-tumor therapy; 3. Gastrointestinal abnormalities, including: inability to take oral drugs; need for intravenous nutrition; previous surgical treatment affecting drug absorption including total gastrectomy; received treatment for active gastric ulcer disease in the past 6 months; past 3 months Active gastrointestinal bleeding unrelated to cancer, including hematemesis, blood in the stool, or melena, without evidence of remission by endoscopy or colonoscopy; malabsorption syndrome. 4. Anticoagulation therapy with oral vitamin K antagonists is required, low-dose anticoagulant drugs are allowed to maintain the patency of central venous access and the prevention of deep vein thrombosis, and low-molecular-weight heparin at therapeutic doses is allowed; 5. The following conditions have occurred within 12 months before administration of the study drug: myocardial infarction, uncontrolled angina pectoris, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack , Deep vein thrombosis or pulmonary embolism within 6 months; 6. Had other malignant diseases. Patients with appropriately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancers who have been disease-free for more than 5 years can be enrolled. 7. Immunodeficiency, HIV-infected persons; 8. Severe heart, lung, liver and kidney insufficiency; 9. Uncontrolled infection or active infection; 10. Active hepatitis B or C; 11. History of active autoimmune disease or autoimmune disease that may recur.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Progression Free Survival; | — |
Countries
China
Contacts
Public ContactZhang Hailiang
Fudan University Shanghai Cancer Center
Outcome results
None listed