Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer

Recruiting now · Phase 3

Conditions studied: Advanced Endometrial Cancer

In brief

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).

Key facts

Study ID

NCT06584032

Run by

Hutchmed

People needed

412

Starts

2024-12-12

Expected to finish

2029-06-09

Last updated by the study team

2025-01-07

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Have fully understood and voluntarily signed the informed consent form
• Age 18 to 75 years (inclusive) ; Body mass index (BMI) ≥ 18.5kg/m\^2;
• Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable lesions
• Patients who previously failed first-line systemic platinum-based therapy
• ECOG PS (Eastern Cooperative Oncology Group performance status score) 0 or 1;
• Need to provide tumor samples for central lab testing of biomarkers such as MSI(microsatellite instability) status;
• Non-MSI-H(non-microsatellite instability-high) by central lab or previous test result indicating pMMR(proficient mismatch repair);
• Adequate function of the major organs;
• Expected survival ≥ 12 weeks;
• Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before randomization.

You may not qualify if…

• Endometrial carcinosarcoma or sarcoma;
• Known MMR(mismatch repair)/MSI status with dMMR(deficient mismatch repair) or MSI-H(microsatellite instability-high);
• Toxicities related to prior anticancer therapy did not recover to ≤CTCAE Grade 1, except alopecia and oxaliplatin-induced peripheral neurotoxicity ≤CTCAE Grade 2;
• Received systemic anti-tumor therapy approved within 4 weeks before randomization;
• Other malignancies within the past 5 years;
• Previous or screening central nervous system (CNS) metastases;
• Radical radiotherapy within 4 weeks before randomization
• Previously received any anti-programmed cell death receptor-1 (PD-1) antibody, anti-PD-L1(programmed death ligand-1) antibody, anti-PD-L2(programmed death ligand-2) antibody, or anti cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody acting on T cell costimulation or checkpoint pathways (eg, OX40, CD137, etc) or small molecule vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors;
• Symptomatic or treatment-requiring thyroid dysfunction at screening;
• Use of immunosuppressive agents within 4 weeks before randomization
• Presence of any active autoimmune disease requiring systemic treatment or history of autoimmune disease within the past 2 years;
• Systemic immunostimulants within 4 weeks before randomization;
• Administration of any live or live-attenuated vaccine within 4 weeks before randomization or planned during the study;
• Major surgical procedures within 4 weeks before randomization;
• Uncontrolled malignant pleural effusion, ascites or pericardial effusion;
• Patients with current hypertension uncontrolled by medication;
• Patients with any current disease or condition affecting drug absorption, or patients unable to take oral medications;
• Receiving strong inducers of cytochrome P450 3A4 enzyme;
• Patients with gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; or with gastrointestinal perforation or gastrointestinal fistula, which is not recovered after surgical treatment;
• Active bleeding within 3 weeks before randomization, or melena, or bleeding from a tumor within 2 weeks before the first dose ;
• Tumor invading major vascular structures and is judged by the investigator to be at greater risk of massive haemorrhage;
• Patients who had arterial thrombosis or deep venous thrombosis within 6 months before randomization; or patients who had stroke events and/or transient ischemic attack within 12 months; patients who had thrombosis caused by implantable intravenous infusion pump or catheter, except patients who had stable thrombosis after conventional anticoagulant therapy;
• Clinically significant cardiovascular disease;
• Clinically significant electrolyte abnormalities as judged by the investigator;
• Active infection or fever of unknown origin before randomization;

Where it is running

• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
• SUN Yat-sen University Cancer Center — Guangzhou, Guangdong, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, 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
• 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
• Beijing Obstetrics and Gynecology Hospital — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
• Chongqing Cancer Hospital — Chongqing, Chongqing Municipality, China
• Fujian Cancer Hospital — Fuzhou, Fujian, China

Full record on ClinicalTrials.gov

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