NCT04387500

Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma

Single-arm Phase II Clinical Trial to Evaluate the Initial Efficacy and Safety of Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of Sintilimab injection combined with Inlyta in fumarate hydratase-deficient renal cell carcinoma.

Detailed description

Our previous genetic research as well as other published data indicated the possible well response to combination of immunotherapy with targeted therapy in FH-deficient renal cell carcinoma, therefore the investigators intented to perform this single-arm phase II clinical trial to evaluate the initial efficacy and safety of Sintilimab injection combined with Inlyta in FH-deficient renal cell carcinoma.

Conditions

• Carcinoma, Renal Cell
• Fumarate Hydratase Deficiency
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Sintilimab injection plus Inlyta treatment	Combined Sintilimab injection and Inlyta treatment in FH-deficient RCC

Timeline

• Start date: 2021-07-01
• Primary completion: 2025-03-01
• Completion: 2026-01-01
• First posted: 2020-05-14
• Last updated: 2024-04-09

Locations

1 site across 1 country: China