Phase II Single-arm Clinical Study of the Efficacy and Safety of Pucotenlimab in Combination With Vorolanib Neoadjuvant Therapy for Patients With High-risk Renal Carcinoma Indicating Partial Nephrectomy
Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, 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)
• Voluntarily sign a written informed consent form (ICF).
• Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender.
• The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1.
• Expected survival period ≥ 3 months.
• Preoperative biopsy pathology confirms renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma
• ECOG score 0 or 1
• The patient is willing to undergo kidney preservation surgery
• Preoperative assessment of healthy kidney GFR\<60 ml/min through renal dynamic imaging
• There are indications for kidney preservation surgery, but the surgery is difficult \[① 4-7cm tumor located at the renal hilum or endogenous ≥ 75% (T1bN0M0); ② Tumors larger than 7cm (T2N0M0)\] 9. There should be at least one measurable lesion (according to mRECIST v1.1 criteria) that is suitable for repeated and accurate measurements.
⁃ Good organ function, laboratory test results during the screening period meet the following criteria:
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• Hematology (no blood components or cell growth factors are allowed to support treatment within 2 weeks before starting treatment):
• a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3); b. Platelet count (PLT) ≥ 100 × 109/L (100000/mm3); c. Hemoglobin (HB) ≥ 90 g/L;
• Liver:
∙ Serum total bilirubin (TBIL) ≤ 1.5 × ULN;
‣ Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT ≤ 5 × ULN
‣ Serum albumin (ALB) ≥ 28g/L
• Coagulation function:
• International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN 11. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.