A Multicenter, Randomized, Open-Label, Active-Controlled Phase II Study Evaluating the Efficacy and Safety of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma
This is a multicenter, randomized, open-label, active-controlled Phase II clinical study evaluating the efficacy and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.
• Male or female, age ≥ 18 years old
• Advanced clear cell renal cell carcinoma confirmed by histology or cytology and not amenable to curative surgery.
• Has not received any previous systemic anti-tumor treatment for advanced renal cell carcinoma.
• Expected survival period is at least 3 months.
• ECOG performance status of 0 or 1, or KPS score of at least 70.
• Has measurable disease per RECIST 1.1.
• Organ function should meet the following criteria:
‣ Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; Platelet (PLT) ≥90×10\^9/L; Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion or hematopoietic stimulator treatment within 7 days).
⁃ Albumin ≥ 30 g/L; Total bilirubin ≤1.5×ULN (for subjects with Gilbert's syndrome, it can be ≤3×ULN); ALT and AST ≤1.5×ULN (If liver metastasis is combined, ALT and AST≤3×ULN).
⁃ Creatinine (Cr) ≤1.5 × ULN; Creatinine clearance (Ccr) (to be calculated only when Cr \> 1.5× ULN) \> 50 ml/min (Cockcroft-Gault formula).
⁃ Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN.
• Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures.