NCT05172440

A Study on the Safety and Effectiveness of Tislelizumab Combined With Axitinib for Neoadjuvant Treatment of ccRCC

A Prospective Clinical Study on the Safety and Effectiveness of Tislelizumab Combined With Axitinib for Neoadjuvant Treatment of Clear Cell Renal Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hongqian Guo · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single-center clinical trial to evaluate the tumor shrinkage and safety of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma

Detailed description

The goal of the study is to use axitinib combined with tislelizumab in the Neoadjuvant therapy of T2-T3 N0M0 renal clear cell carcinoma to shrink tumors or tumor thrombi, reduce the complexity of surgery, and achieve kidney Partial resection or enucleation of renal tumors instead of kidney Partial resection, or unresectable renal tumors can be changed to resectable and improve the patient's prognosis. The primary endpoint is the tumor shrinkage effect of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma. The secondary end point is * The safety and downgrading rate of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma； * Two-year disease-free survival (DFS) of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma； * Explore biomarkers in tumor tissue and blood that may be related to the efficacy of neoadjuvant therapy and the prognosis of subjects;

Conditions

• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	tislelizumab combined with axitinib	Subjects received axitinib 5 mg bid, 12 weeks, and tislelizumab 200 mg on the first day of the first week, 4th week, 7th week, and 10th week, and intravenous infusion. With 21 days as a treatment cycle, 4 cycles of treatment, namely 12 weeks. Axitinib was discontinued for 12 weeks after the completion of treatment, and surgery was performed 7 days later.

Timeline

• Start date: 2021-12-09
• Primary completion: 2023-11-20
• Completion: 2024-10-01
• First posted: 2021-12-29
• Last updated: 2021-12-29

Locations

1 site across 1 country: China