Through the neoadjuvant treatment with a combination of Cadonilimab 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 (tumors measuring 4-7 cm located at the renal hilum or with endophytic growth ≥75% or tumors \>7 cm)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
* Lenvatinib Treatment Lenvatinib (8mg \[body weight \< 60 kg\] or 12 mg \[body weight ≥ 60 kg\]) orally once daily, with or without food. * Intravenous Infusion of Cadonilimab (Injection) Infuse Cadonilimab at a dose of 6mg/kg intravenously every two weeks, constituting one treatment cycle, a total of 3 or 6 cycles.
Sun Yat-sen University Cancer Center
Guangzhou, Other (Non U.s.), China
ORR
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
Time frame: Evaluation at the end of Cycle 3 or 6 (each cycle is 14 days) of Cadonilimab treatment
Major Pathological Response rate (MPR)
The proportion of patients with residual viable tumor cells in tumor specimens and lymph nodes resected after neoadjuvant therapy, which are ≤10%.
Time frame: The evaluation was conducted 5 days after surgery.
Nephron-sparing surgery (NSS) success rate
The success rate of all enrolled patients undergoing partial nephrectomy.
Time frame: Evaluation at the end of surgery.
R0 resection rate
R0 resection rate refers to the percentage of patients in whom a tumor is surgically removed with no microscopic residual disease. Specifically, it means that after pathological examination of the resected specimen, the tumor margins are negative (no cancer cells are found at the cut edge).
Time frame: The evaluation was conducted 5 days after surgery.
Surgical complication rate
Surgical complication rate is the proportion of patients who experience any unintended, adverse event (such as infection, bleeding, organ injury, or anastomotic leak) following a surgical procedure
Time frame: From the end of surgery to three months after surgery
Drug safety profile
Incidence and severity of adverse events during the use of Cadonilimab and Lenvatinib.
Time frame: During the treatment of combination of Cadonilimab and Lenvatinib.
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