NCT06584032 Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer
| NCT ID | NCT06584032 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hutchmed |
| Condition | Advanced Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 412 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2029-01-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 412 participants in total. It began in 2024-12-12 with a primary completion date of 2029-01-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Have fully understood and voluntarily signed the informed consent form 2. Age 18 to 75 years (inclusive) ; Body mass index (BMI) ≥ 18.5kg/m\^2; 3. Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable lesions 4. Patients who previously failed first-line systemic platinum-based therapy 5. ECOG PS (Eastern Cooperative Oncology Group performance status score) 0 or 1; 6. Need to provide tumor samples for central lab testing of biomarkers such as MSI(microsatellite instability) status; 7. Non-MSI-H(non-microsatellite instability-high) by central lab or previous test result indicating pMMR(proficient mismatch repair); 8. Adequate function of the major organs; 9. Expected survival ≥ 12 weeks; 10. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before randomization. Exclusion Criteria: 1. Endometrial carcinosarcoma or sarcoma; 2. Known MMR(mismatch repair)/MSI status with dMMR(deficient mismatch repair) or MSI-H(microsatellite instability-high); 3. Toxicities related to prior anticancer therapy did not recover to ≤CTCAE Grade 1, except alopecia and oxaliplatin-induced peripheral neurotoxicity ≤CTCAE Grade 2; 4. Received systemic anti-tumor therapy approved within 4 weeks before randomization; 5. Other malignancies within the past 5 years; 6. Previous or screening central nervous system (CNS) metastases; 7. Radical radiotherapy within 4 weeks before randomization 8. 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; 9. Symptomatic or treatment-requiring thyroid dysfunction at screening; 10. Use of immunosuppressive agents within 4 weeks before randomization 11. Presence of any active autoimmune disease requiring systemic treatment or history of autoimmune disease within the past 2 years; 12. Systemic immunostimulants within 4 weeks before randomization; 13. Administration of any live or live-attenuated vaccine within 4 weeks before randomization or planned during the study; 14. Major surgical procedures within 4 weeks before randomization; 15. Uncontrolled malignant pleural effusion, ascites or pericardial effusion; 16. Patients with current hypertension uncontrolled by medication; 17. Patients with any current disease or condition affecting drug absorption, or patients unable to take oral medications; 18. Receiving strong inducers of cytochrome P450 3A4 enzyme; 19. 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; 20. Active bleeding within 3 weeks before randomization, or melena, or bleeding from a tumor within 2 weeks before the first dose ; 21. Tumor invading major vascular structures and is judged by the investigator to be at greater risk of massive haemorrhage; 22. 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; 23. Clinically significant cardiovascular disease; 24. Clinically significant electrolyte abnormalities as judged by the investigator; 25. Active infection or fever of unknown origin before randomization; 26. Patients with active pulmonary tuberculosis (TB) receiving anti-tuberculosis treatment or anti-tuberculosis treatment within 1 year before randomization; 27. Patients with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, which may interfere with the detection and management of suspected drug-related pulmonary toxicity; previous or current (non-infectious) pulmonary inflammation requiring steroid hormone therapy; 28. Positive human immunodeficiency virus (HIV) antibody screening; 29. Known history of clinically significant liver disease 30. Known hypersensitivity to any of the study drugs or any of their excipients, or previous history of serious hypersensitivity to any other monoclonal antibody; 31. Patients who have received other clinical drugs that have not been approved or marketed within 4 weeks before randomization; 32. Women who are pregnant (positive pregnancy test before medication) or breastfeeding; 33. Patients who have received tissue/organ transplantation; 34. Patients with known psychiatric disorders or substance abuse disorders that could affect study compliance; 35. Patients who, in the opinion of the investigator, have other reasons that would make them inappropriate for this clinical study.
Contact & Investigator
Xiaohua Wu
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06584032 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Advanced Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06584032 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 412 participants.
Is NCT06584032 currently recruiting?
Yes, NCT06584032 is actively recruiting participants. Contact the research team at panfengt@hutch-med.com for enrollment information.
Where is the NCT06584032 trial being conducted?
This trial is being conducted at Beijing, China, Chongqing, China, Fuzhou, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT06584032 clinical trial?
NCT06584032 is sponsored by Hutchmed. The principal investigator is Xiaohua Wu at Fudan University. The trial plans to enroll 412 participants.
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