Status:
RECRUITING
Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer
Lead Sponsor:
Hutchmed
Conditions:
Advanced Endometrial Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
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).
Detailed Description
A randomized, open, positive-controlled, multicenter Phase III clinical study to compare the efficacy and safety of fruquintinib(HMPL-013) plus sintilimab(IBI308) versus chemotherapy in patients with ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Patients with active pulmonary tuberculosis (TB) receiving anti-tuberculosis treatment or anti-tuberculosis treatment within 1 year before randomization;
- 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;
- Positive human immunodeficiency virus (HIV) antibody screening;
- Known history of clinically significant liver disease
- Known hypersensitivity to any of the study drugs or any of their excipients, or previous history of serious hypersensitivity to any other monoclonal antibody;
- Patients who have received other clinical drugs that have not been approved or marketed within 4 weeks before randomization;
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- Patients who have received tissue/organ transplantation;
- Patients with known psychiatric disorders or substance abuse disorders that could affect study compliance;
- Patients who, in the opinion of the investigator, have other reasons that would make them inappropriate for this clinical study.
Key Trial Info
Start Date :
December 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 9 2029
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT06584032
Start Date
December 12 2024
End Date
June 9 2029
Last Update
January 7 2025
Active Locations (17)
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1
Beijing Obstetrics and Gynecology Hospital
Beijing, Beijing Municipality, China, 100026
2
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
4
SUN Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510050