Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07170982
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2025-10-15

Completion Date

2029-10-15

Last Updated

2025-09-12

Healthy Volunteers

No

Interventions

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.

Locations (1)

Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China