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Clinical Trials in China / NCT06584032
Recruiting Phase 3

Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer

NCT06584032 · tracked via the Priya Life Science China tracker
Sponsor
Hutchmed
Phase
Phase 3
Started
2024-12-12
Last updated
2025-01-07

Condition(s) studied

Advanced Endometrial Cancer

Investigational drug(s) / intervention(s)

fruquintinibsintilimabpaclitaxeldoxorubicin

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

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

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

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

Study 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
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
Beijing Obstetrics and Gynecology Hospital Beijing Beijing Municipality Not Yet Recruiting
Chongqing Cancer Hospital Chongqing Chongqing Municipality Not Yet Recruiting
Fujian Cancer Hospital Fuzhou Fujian Not Yet Recruiting
SUN Yat-sen University Cancer Center Guangzhou Guangdong Not Yet Recruiting
Guangxi Medical University Cancer Hospital Nanning Guangxi Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Not Yet Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Hunan Cancer Hospital Changsha Hunan Not Yet Recruiting
Xijing Hospital of Air Force Military Medical University Xi'an Shaanxi Not Yet Recruiting
Shandong Cancer Hospital Jinan Shandong Not Yet Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Sencond Hospital of Shanxi Medical University Taiyuan Shanxi Not Yet Recruiting
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality Not Yet Recruiting
Yunnan Cancer Hospital Kunming Yunnan Not Yet Recruiting
Women's Hospital school of Medical Zhejiang University Hangzhou Zhejiang Not Yet Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Not Yet Recruiting
The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Not Yet Recruiting

More Hutchmed trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06584032 on ClinicalTrials.gov ↗ ← All trials in China