NCT06523049

Vorolanib Plus Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy

A Prospective, Multicenter, Phase II Clinical Trial of Vorolanib in Combination With Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Hao Zeng · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase II trial assesses Vorolanib and Sintilimab for advanced renal cell carcinoma after previous therapy failure. Participants receive the treatment until disease progression, intolerable side effects, death, or withdrawal. The primary endpoint is progression-free survival (PFS).

Detailed description

This is a Phase II, multicenter, single-arm clinical trial designed to assess the efficacy and safety of Vorolanib in combination with Sintilimab in treating advanced renal cell carcinoma following the failure of prior immune checkpoint inhibitors based combination therapy. Participants will continue to receive Vorolanib and Sintilimab until disease progression, development of unacceptable toxic effects, death, or if the physician or patient decides to withdraw from the study. The primary endpoint is progression-free survival (PFS) according to RECIST v1.1 criteria as evaluated by the investigators.

Conditions

• Renal Cell Carcinoma
• Immunotherapy
• Molecular Targeted Therapy

Interventions

Type	Name	Description
DRUG	Vorolanib Tablets	Multi-targeted receptor tyrosine kinase inhibitor with potent inhibition of VEGFR2, KIT, PDGFR, FLT3 and RET, exerting anti-tumor effects mainly through inhibition of neovascularization.
DRUG	Sintilimab Injection	Recombinant human-derived immunoglobulin G (IgG4)-type anti-programmed cell death receptor-1 (PD-1) monoclonal antibody, by binding to PD-1 and blocking PD-1 binding to PD-L1 and PD-L2, disarms the immunosuppressive effect, activates T-cell function, and enhances T-cell immunosurveillance and killing ability against tumors to generate tumor immune response.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2024-07-26
• Last updated: 2024-07-26

Locations

1 site across 1 country: China