A Prospective, Multicenter, Single-arm Clinical Study of the Efficacy and Safety of Toripalimab in Combination With Axitinib for Postoperative Adjuvant Therapy for Non-clear Renal Cell Carcinoma With High-risk Recurrence Factors
The goal of this prospective, multicenter, single-arm clinical study is to evaluate the efficacy and safety of toripalimab in combination with axitinib for postoperative adjuvant therapy for non-clear renal cell carcinoma with high-risk recurrence factors.
• Age 18-75 years old
• Participants with histologically confirmed non-clear renal cell carcinoma except clear cell RCC, chromophobe RCC and eosinophilic RCC, and must meet any of the following conditions:
∙ histologically confirmed Papillary RCC, pT≥T1b and ISUP/WHO ≥3, N (any), M0;
‣ Collecting duct carcinoma, SMARCB1-deficient renal medullary carcinoma, fumarate hydratase deficiency renal cell carcinoma (FH-RCC), pT (any), ISUP/WHO (any), N (any), M0.
‣ Non-clear renal cell carcinoma except Organizational Credits Type a and b, including but not limited to TFE3/TFEB translocated RCC or unclassified RCC, pT (any), ISUP/WHO ≥ grade 3, N (any), M0;
• Patients who have completely resected the primary tumor (partial or radical nephrectomy), and M1 NED patients who have completely resected solid, isolated soft tissue metastases.
• Patients who have completely removed the renal tumor. The nephrectomy must be performed ≥ 3 weeks but ≤ 12 weeks before randomization. Partial nephrectomy and renal tumor enucleation are permitted;
• Patients must have no clinical or radiographic evidence of macroscopic residual lesions or distant metastasis (M0) after surgery. M1 participants must have no evidence of disease (M1 NED);
• ECOG performance status 0-1 ;
• Patients must have not received systemic therapy for renal tumors;
• Adequate hematopoiesis and organ function:
‣ Hematopoietic function: Absolute neutrophil count (ANC) ≥1.5×109/L; platelets≥ 100×109/L; Hemoglobin≥ 9.0g/dL;
⁃ Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance \> 50 mL/min;
⁃ Liver function: total bilirubin ≤1.5×ULN or total bilirubin \>1.5×ULN but direct bilirubin normal; AST and ALT≤2.5×ULN;
⁃ Coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN;
⁃ Left ventricular ejection fraction (LVEF) ≥ 50%;
• Signed informed consent form;
⁃ Patients and/or their partner are willing to use highly effective forms of contraception and to continue its use 3 months after the last dose of drugs.
⁃ Ability and capacity to comply with study and follow-up procedures.