Phase II Single-arm Clinical Study of the Efficacy and Safety of Cadonilimab in Combination With Lenvatinib Neoadjuvant Therapy for Patients With High-risk Renal Carcinoma Indicating Partial Nephrectomy
Through the neoadjuvant treatment with a combination of Cardonilli and Lenvatinib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an endophytic component ≥75% or T2)
• Voluntary written informed consent (ICF).
• Age ≥18 years old at the time of enrollment, male or female.
• The Eastern United States Cancer Collaboration (ECOG) Physical Fitness score is 0 or 1.
• Expected survival ≥3 months.
• Preoperative biopsy pathologically confirmed clear cell carcinoma of kidney or renal cell carcinoma dominated by clear cell carcinoma
• ECOG score 0 or 1
• The patient has the intention of kidney preservation operation
• There are indications for kidney-preserving surgery, but the operation is difficult (T1b endogenous ≥75% or T2).
• Have at least one measurable lesion (according to mRECIST v1.1) suitable for repeated accurate measurement.
⁃ Good organ function, laboratory test results during the screening period meet the following criteria:
‣ (1) Hematology (no use of blood components and cell growth factors to support therapy within 2 weeks before starting treatment) :
• neutrophil absolute value (ANC) ≥ 1.5×109/L (1,500/mm3);
• Platelet count (PLT) ≥ 100×109/L (100,000/mm3);
• Hemoglobin (HB) ≥ 90 g/L; (2) Liver:
‣ a. Serum total bilirubin (TBIL) ≤ 1.5×ULN; b. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5×ULN; For subjects with liver metastasis, AST and ALT ≤ 5×ULN c. Serum albumin (ALB) ≥28g/L (3) Coagulation function: International Standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN 11. Subject is willing and able to comply with scheduled visits, treatment protocols, laboratory tests, and other requirements of the study.