NCT07170982

Fruquintinib Combined With Standard Chemotherapy Versus Standard Chemotherapy as First-line Treatment for Advanced pMMR Endometrial Cancer

A Randomized, Controlled, Multicenter Clinical Study of Fruquintinib Combined With Standard Chemotherapy Versus Standard Chemotherapy as First-line Treatment for Advanced pMMR Endometrial Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, multicenter clinical study designed to explore the safety and efficacy of fruquintinib combined with standard chemotherapy versus standard chemotherapy as first-line treatment for advanced mismatch repair-intact (pMMR) endometrial cancer. The standard chemotherapy regimen is TC (paclitaxel + carboplatin); Safety introduction period (N=12): Dose expansion phase (N=116): Subjects who met the inclusion criteria were randomly assigned 1:1 to the following treatment groups: Experimental group: fruquintinib + standard chemotherapy (trial drugs include fruquintinib); Control group: standard chemotherapy TC regimen (paclitaxel + carboplatin); The study treatment cycle was 21 days, with a maximum of 6 cycles of paclitaxel and carboplatin. Patients who achieved disease control or better entered the maintenance treatment phase. The experimental group received maintenance treatment with fruquintinib monotherapy until one of the following conditions occurred: PD (except for cases where continued treatment after PD was allowed as stipulated in the protocol), death, intolerable toxicity, or other criteria for termination of study treatment stipulated in the protocol, whichever occurred first.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib	This study aims to confirm the safety and efficacy of fruquintinib combined with standard chemotherapy, further compare whether first-line standard chemotherapy has superiority, bring better survival benefits to patients with pMMR endometrial cancer, and provide more options for patients with late recurrent and metastatic endometrial cancer.

Timeline

• Start date: 2025-10-15
• Primary completion: 2027-10-15
• Completion: 2029-10-15
• First posted: 2025-09-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: China