Renal cell carcinoma
Conditions
Interventions
Experimental group:Sullimumab: intravenous injection, 200mg each time, administered once every 3 weeks. Until progressive disease (PD) or medication for 1 year.
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years old; 2. Histologically confirmed as localized non metastatic renal cell carcinoma with the following high-risk factors for recurrence or metastasis: T2 stage and cell grade 4 or sarcomatoid differentiation; Greater than or equal to T3; Regional lymph node metastasis; Or metastatic renal cell carcinoma with complete resection of the metastatic lesion. The patient did not receive any systemic treatment for renal cell carcinoma prior to enrollment, including cytokines, targeted drugs, or immunotherapy. Surgery (partial or radical nephrectomy or metastatic resection) must have been performed within 12 weeks prior to enrollment, with a negative surgical margin. For patients with concurrent metastases, the metastatic tumor must be completely removed during nephrectomy or within 1 year after nephrectomy. 3. ECOG score: 0-1 points; 4. Expected survival period >= 3 months; 5. The main organ functions are normal, which meets the following criterias: (1) The blood routine examination standards must comply with (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulating factors corrected): a.HB >=90 g/L; b.ANC >=1.5×10^9/L; c.PLT>=80×10^9/L; (2) Biochemical tests must meet the following standards: a. TBIL45 ml/min (Cockcroft Gault formula); 6. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with negative results, and be willing to use appropriate contraception methods during the trial period and 8 weeks after the last administration of the trial drug. For males, they must agree to use appropriate contraception methods or undergo surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug; 7. The subjects voluntarily joined this study and signed an informed consent form, with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Renal cell carcinoma metastasizes and cannot completely remove the primary or metastatic lesion; Patients with renal cell carcinoma who have not undergone radical nephrectomy or nephrectomy; Patients who have previously received systemic anti-tumor therapy. 2. Pregnant or lactating women; Patients with fertility who are unwilling or unable to take effective contraceptive measures; 3. Patients with organ failure; 4. ECOG>2 points; 5. Persons with uncontrollable infectious diseases or other serious diseases, such as HIV positive, active hepatitis; 6. Patients with systemic autoimmune diseases or immunodeficiency diseases; 7. Patients with allergies or chronic diseases that require immunotherapy or hormone therapy; 8. Uncontrollable hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite optimal drug treatment); 9. Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >= 450 ms for males and >= 470 ms for females); 10. According to NYHA standards, patients with grade III-IV cardiac dysfunction or those with left ventricular ejection fraction (LVEF)1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy; 12. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or similar drugs; 13. Within the first 2 months of randomization, there was a significant cough of fresh blood or a daily hemoptysis volume of half a teaspoon (2.5ml) or more; 14. Within the first 3 months of randomization, there have been significant clinical bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++or above, or vasculitis; 15. Arterial/venous thrombotic events that occurred within the first 12 months of randomization, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 16. Known genetic or acquired bleeding and thrombophilia tendencies (such as in hemophilia patients, coagulation dysfunction, thrombocytopenia, splenic hyperfunction, etc.); 17. Long term untreated wounds or fractures; 18. Have undergone major surgical procedures or experienced severe traumatic injuries, fractures, or ulcers within the first 4 weeks of randomization; 19. Urine routine test indicates urinary protein >=++, or confirms 24-hour urinary protein level >= 1.0 g; 20. Serous fluid accumulation (including pleural effusion, ascites, and pericardial effusion) with clinical symptoms that require surgical treatment; 21. Patients with active hepatitis B or C virus infection; 22. Active infections that require antimicrobial therapy (such as treatment with antibiotics, antiviral drugs, or antifungal drugs); 23. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 24. Those who have participated in clinical trials of other anti-tumor drugs within the first 4 weeks of randomization; 25. Those who have used systemic chemotherapy drugs before randomization; 26. Previous or concurrent untreated malignant tumors; 27. Pregnant or lactating women; Patients with fertility who are unwilling or unable to take effective contraceptive measures; 28
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Disease specific survival (DSS);Safety; | — |
Countries
China
Contacts
Public ContactHua Wang
Zhejiang Cancer Hospital
Outcome results
None listed