The Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) Combined With Lenvatinib as Neoadjuvant Therapy in Renal Cancer With Partial Nephrectomy Indications But High Surgical Risk:A Single Arm, Phase II Clinical Study
Through the combination of aparolitovorelli monoclonal antibody and lenvatinib neoadjuvant therapy, partial nephrectomy can be successfully and safely performed in patients with localized renal cell carcinoma (T1N0M0 or T2N0M0) who have indications for kidney preservation surgery but have difficulty in preserving the kidney (R.E.N.A.L. score \>= 10).
• Voluntarily sign a written informed consent form (ICF).
• Age at the time of enrollment is \>= 18 and under 80 years old, with no gender restrictions.
• 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 confirmed 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;
• Indications for kidney preservation surgery are available, but limited renal cancer with high difficulty of kidney preservation surgery (stage T1N0M0 or T2N0M0, must meet R.E.N.A.L. score \>= 10);
• At least one measurable lesion (according to mRECIST v1.1 standard) that is suitable for repeated and accurate measurements.
⁃ Good organ function, screening laboratory test results meet the following criteria: (1) 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 × 10\^9/L (1500/mm\^3); b. Platelet count (PLT) \>= 100 × 10\^9/L (100000/mm\^3); c. Hemoglobin (HB) \>= 90 g/L; (2) Liver: a. Serum total bilirubin (TBIL) \<= 1.5 × ULN; b. Alanine transaminase (ALT) and aspartate transaminase (AST) \<= 2.5 × ULN; For subjects with liver metastases, AST and ALT are \<= 5 × ULN, while serum albumin (ALB) is \>= 28g/L. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) are \<= 1.5 × ULN;
⁃ The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.