NCT06584032

Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer

A Randomized,Open-label,Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab Versus Chemotherapy of the Treating Physician's Choice as Second-line Treatment for Advanced Endometrial Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (estimated)
• Sponsor: Hutchmed · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC).

Detailed description

A randomized, open, positive-controlled, multicenter Phase III clinical study to compare the efficacy and safety of fruquintinib(HMPL-013) plus sintilimab(IBI308) versus chemotherapy in patients with advanced endometrial cancer who have progressed after first-line standard chemotherapy

Conditions

• Advanced Endometrial Cancer

Interventions

Type	Name	Description
DRUG	fruquintinib	Fruquintinib will be orally administrated once daily for 2 consecutive weeks followed by a 1-week break.
BIOLOGICAL	sintilimab	Sintilimab will be intravenously administrated on Day 1 every three weeks.
DRUG	paclitaxel	175 mg/m\^2 via IV infusion, once a week for 3 weeks followed by a 1-week break.
DRUG	doxorubicin	60mg/m\^2 via IV infusion, on Day 1 every three weeks.

Timeline

• Start date: 2024-12-12
• Primary completion: 2029-01-08
• Completion: 2029-06-09
• First posted: 2024-09-04
• Last updated: 2025-01-07

Locations

17 sites across 1 country: China