This study is a randomized, parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus chemotherapy as second-line treatment in subjects with advanced biliary cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
392
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;
Anhui Provincal Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGOverall survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 40 weeks
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 24 weeks
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 24 weeks
Disease control rate(DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 24 weeks
Duration of response(DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 24 weeks
Progression-free survival at 6 months
Percentage of participants whose PFS has achieved at least 6 months.
Time frame: up to 6 months
Overall survival at 6 months
Percentage of participants whose OS has achieved at least 6 months.
Time frame: up to 6 months
Overall survival at 12 months
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Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;
Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Youan Hospital,Captical Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGAffiliated Hospital of Hebei University
Baoding, Hebei, China
NOT_YET_RECRUITINGCangzhou Central Hospital
Cangzhou, Hebei, China
NOT_YET_RECRUITING...and 7 more locations
Percentage of participants whose OS has achieved at least 12 months.
Time frame: up to 12 months