NCT06279403

Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma

Upfront Toripalimab Plus Axitinib Combined With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma. Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells \<10% in the primary tumor after nephrectomy. Study Design: Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs. Sample Size: 20 participants. Patient Grouping: Non-randomized. Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery.

Conditions

• Clear-cell Metastatic Renal Cell Carcinoma
• Immune Checkpoint Inhibitors
• Cytoreductive Nephrectomy

Interventions

Type	Name	Description
DRUG	Toripalimab	Preoperative Treatment with Toripalimab: Administer 240mg of Toripalimab via intravenous infusion every 3 weeks for a total of 4 cycles.
PROCEDURE	Cytoreductive Nephrectomy	Radical Nephrectomy: Complete resection of the tumor and affected kidney within the renal fascia. Partial Nephrectomy: Complete resection of the tumor while preserving maximal kidney function. Lymph Node Dissection: For patients with evident enlargement of retroperitoneal lymph nodes preoperatively, perform lymph node dissection at the renal hilum, along the ipsilateral major vessels, and anterior to the ipsilateral major vessels. Lymph node dissection is not required for patients without evident enlargement of retroperitoneal lymph nodes preoperatively.
DRUG	Axitinib	Preoperative Treatment with Axitinib: Administer 5mg of axitinib orally twice daily for a duration of 3 months.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-01
• Completion: 2029-03-01
• First posted: 2024-02-28
• Last updated: 2024-02-28