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).
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 advanced endometrial cancer who have progressed after first-line standard chemotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
412
Fruquintinib will be orally administrated once daily for 2 consecutive weeks followed by a 1-week break.
Sintilimab will be intravenously administrated on Day 1 every three weeks.
175 mg/m\^2 via IV infusion, once a week for 3 weeks followed by a 1-week break.
Beijing Obstetrics and Gynecology Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGProgression-Free Survival (PFS) as assessed by IRC
Progression-free survival (PFS) is defined as the time from randomization to disease progression assessed by IRC or death due to any cause, whichever occurs first.
Time frame: Up to approximately 4 years
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 4 years
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR) , as assessed by IRC and investigator.
Time frame: Up to approximately 4 years
Duration of Response (DoR)
For patients who reached complete response (CR) or partial response (PR), Duration of Response (DoR) is defined as the time from the first CR or PR until disease progression or death due to any cause, whichever occurs first ,as assessed by IRC and investigator.
Time frame: Up to approximately 4 years
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR) or maintained a stable disease, as assessed by IRC and investigator.
Time frame: Up to approximately 4 years
Time To Response (TTR)
Time To Response (TTR) is defined as the time from the start of treatment to the first objective response rate (ORR) ,as assessed by IRC and investigator.
Time frame: Up to approximately 4 years
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60mg/m\^2 via IV infusion, on Day 1 every three weeks.
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGSUN Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGXijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China
NOT_YET_RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
NOT_YET_RECRUITING...and 7 more locations
Progression-Free Survival (PFS) as assessed by investigator
Progression-Free Survival is defined as the time from randomization to disease progression assessed by investigator or death due to any cause, whichever occurs first.
Time frame: Up to approximately 4 years
Incidence and severity of Treatment-emergent Adverse Events (TEAE)
Adverse events classified according to NCI CTCAE version 5.0
Time frame: Up to approximately 4 years
Blood concentration of fruquintinib
Steady-state blood concentration of fruquintinib
Time frame: At the end of cycle 4 day 14 (each cycle is 21 days)
Health-related quality of life (using EORTC QLQ-C30)
Changes in EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) scores from baseline
Time frame: Up to approximately 4 years
Health-related quality of life (using EORTC QLQ-EN24)
Changes in EORTC QLQ-EN24 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module) scores from baseline
Time frame: Up to approximately 4 years