Cadonilimab combined with lenvatinib for neoadjuvant therapy in early-stage renal cell carcinoma with indications for partial nephrectomy but high surgical risk: A prospective single-arm phase II clinical trial.

• DOI: 10.1200/jco.2025.43.5_suppl.530
• Publication Date: 2025-02-18T14:40:47Z
• Authors: Yulu Peng; Pei Dong; Hui Han; Fangjian Zhou; Zhiling Zhang
• Keywords: Lenvatinib; Neoadjuvant Therapy

530 Background: Partial nephrectomy is the standard treatment for early-stage renal cell carcinoma; however, in some patients, although tumor early-stage, surgical difficulty may preclude its implementation. This study aims to evaluate efficacy and safety of Cadonilimab combined with Lenvatinib neoadjuvant therapy carcinoma indications partial but high risk. Methods: a single-center, single-arm Phase II clinical trial. Eligible patients included those biopsy-confirmed clear who had were at risk (criteria: 1. tumors measuring 4-7 cm located hilum or endophytic ≥75%; 2. larger than 7 cm). Patients received dosage 8 mg 12 QD 6 mg/kg every two weeks 3-6 cycles, total duration 6-12 weeks. first-in-class bispecific antibody targeting both PD-1 CTLA-4. All are scheduled undergo after therapy. The primary endpoint was objective response rate (ORR) based on RECIST 1.1 criteria. Secondary endpoints preservation success rate, safety, incidence perioperative complications. Results: A 27 enrolled study. Sixteen completed cycles treatment, 3 5 did not complete pre-set cycles. One patient underwent surgery experiencing grade 4 adverse event (diabetic ketoacidosis) following second cycle Cadonilimab; four discontinued subjective reasons proceeded cycle. procedures. ORR 55.6% (15/27), control 100%. demonstrated reduction prior nephrectomy, an average maximum diameter 26.5%. Furthermore, 100% nephrectomy. Two achieved pathological response, all exhibited necrosis, necrosis 45%. Adverse events (AEs) ≥3 occurred 10.5% including hyperglycemia elevated ALT/AST. experienced AE, no postoperative complications reported. main limitation this that it small-sample Conclusions: early demonstrates warranting further validation. Clinical trial information: NCT06138496 .