RecruitingPhase 3NCT06584032

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


Sponsor

Hutchmed

Enrollment

412 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — fruquintinib (a targeted therapy) and sintilimab (an immunotherapy) — in women with advanced or recurrent endometrial (uterine) cancer that has already been treated with chemotherapy. **You may be eligible if...** - You are between 18 and 75 years old with a BMI of at least 18.5 - You have confirmed advanced or recurrent endometrial cancer with measurable disease - You have already received at least one prior platinum-based chemotherapy regimen - Your overall health status is rated 0–1 on standard performance scales - Your major organ functions (heart, liver, kidneys) are within acceptable ranges **You may NOT be eligible if...** - You have uncontrolled high blood pressure, active bleeding, or recent blood clots - You have received prior treatment with fruquintinib, sintilimab, or similar drugs - You are pregnant or breastfeeding - You have an active autoimmune disease requiring treatment - You have untreated brain metastases - You have serious heart conditions or unhealed wounds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGfruquintinib

Fruquintinib will be orally administrated once daily for 2 consecutive weeks followed by a 1-week break.

BIOLOGICALsintilimab

Sintilimab will be intravenously administrated on Day 1 every three weeks.

DRUGpaclitaxel

175 mg/m\^2 via IV infusion, once a week for 3 weeks followed by a 1-week break.

DRUGdoxorubicin

60mg/m\^2 via IV infusion, on Day 1 every three weeks.


Locations(17)

Beijing Obstetrics and Gynecology Hospital

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

SUN Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Xijing Hospital of Air Force Military Medical University

Xi'an, Shaanxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Sencond Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Women's Hospital school of Medical Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06584032


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