A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Sintilimab Versus Axitinib or Everolimus as Second-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (FRUSICA-2)

NCT05522231 Phase 2/Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Hutchmed
Phase	Phase 2/Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	265
Start date	2022-10-27
Completion	2025-03

Conditions

• Advanced Renal Cell Carcinoma

Interventions

• fruquintinib+sintilimab
• axitinib / everolimus
• fruquintinib

Primary outcomes

• Progression free survival (PFS) in Part I — Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
  PFS per RECIST 1.1 by BIRC
• Objective response rate (ORR) in Part II — Time from the date of first treatment administration until disease progression or the introduction of a new treatment, assessed up to 20 months.
  ORR per RECIST 1.1 by investigator

Countries

China