Clinical Trial

Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)

Active, Not Recruiting Phase 2/3
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Summary
The study consists of two parts, the first part is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy as second-line treatment for locally advanced or metastatic renal cell carcinoma. The second part is a fruquintinib monotherapy factorial cohort study to evaluate the efficacy and safety of fruquintinib monotherapy as for second-line treatment of locally advanced or metastatic renal cell carcinoma.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-08-29; most recent amendment 2025-01-01.
Status change: Recruiting → Active, Not Recruiting 2025-01-01
Status change: Not Yet Recruiting → Recruiting 2023-07-09
Trial Details
NCT Number NCT05522231
Lead Sponsor Hutchmed
Conditions Advanced Renal Cell Carcinoma
Enrollment 265 participants
Start Date 2022-10-27
Primary Completion 2025-01 (estimated)
Study Completion 2025-03 (estimated)
Updated on ClinicalTrials.gov 2025-01-03