Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer
ConditionAdvanced Endometrial Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorHutchmed
About this trial
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
Qualifiers
Have fully understood and voluntarily signed the informed consent form
Age 18 to 75 years (inclusive) ; Body mass index (BMI) ≥ 18.5kg/m²;
Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable lesions
Patients who previously failed first-line systemic platinum-based therapy
Disqualifiers
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;
Trial design
Treatments tested in this trial
- fruquintinib
- sintilimab
- paclitaxel
- doxorubicin
Treatment groups
412 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov