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

NCT07170982 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-09-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jihong Liu, Ph. D · Sun Yat-sen University Cancer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2027-10-15
Completion
2029-10-15

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07170982 on ClinicalTrials.gov