A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer

PHASE3UnknownINTERVENTIONAL
Enrollment

392

Participants

Timeline

Start Date

February 4, 2021

Primary Completion Date

March 18, 2022

Study Completion Date

February 1, 2023

Conditions
Advanced Biliary Cancer
Interventions
DRUG

TQB2450 Injection

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.

DRUG

Anlotinib hydrochloride

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).

DRUG

Oxaliplatin injection

Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;

DRUG

Capecitabine tablets

Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;

DRUG

Gemcitabine hydrochloride injection

Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.

Trial Locations (17)

100020

NOT_YET_RECRUITING

Beijing Chao-Yang Hospital,Capital Medical University, Beijing

100021

NOT_YET_RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100044

NOT_YET_RECRUITING

Peking University People's Hospital, Beijing

100069

NOT_YET_RECRUITING

Beijing Youan Hospital,Captical Medical University, Beijing

100089

RECRUITING

Beijing Cancer Hospital, Beijing

102218

NOT_YET_RECRUITING

Beijing Tsinghua Changgung Hospital, Beijing

130000

NOT_YET_RECRUITING

The First Bethune Hospital of Jilin University, Changchun

150081

NOT_YET_RECRUITING

Harbin Medical University Affiliated Tumor Hospital, Harbin

213000

NOT_YET_RECRUITING

The First Peoples Hospital of Changzhou, Changzhou

230001

NOT_YET_RECRUITING

Anhui Provincal Hospital, Hefei

350001

NOT_YET_RECRUITING

Fujian Medical University Union Hospital, Fuzhou

410000

NOT_YET_RECRUITING

Hunan Provincial People's Hospital, Changsha

430040

NOT_YET_RECRUITING

Tongji Medical College of HUST, Wuhan

450003

NOT_YET_RECRUITING

Henan Tumor Hospital, Zhengzhou

071000

NOT_YET_RECRUITING

Affiliated Hospital of Hebei University, Baoding

061001

NOT_YET_RECRUITING

Cangzhou Central Hospital, Cangzhou

067000

NOT_YET_RECRUITING

Affiliated Hospital of Chengde Medical University, Chengde

All Listed Sponsors
lead

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY