A Study of Anlotinib Hydrochloride Capsule Combined With AK105 Injection in Subject With Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma

PHASE3UnknownINTERVENTIONAL
Enrollment

528

Participants

Timeline

Start Date

May 20, 2020

Primary Completion Date

October 31, 2023

Study Completion Date

December 31, 2023

Conditions
Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
Interventions
DRUG

Anlotinib hydrochloride capsule

Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

DRUG

AK105 injection

AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle.

DRUG

Paclitaxel injection

Paclitaxel injection 80mg / m² IV on Days 1, 8 and 15 of each 28-day cycle.

DRUG

Docetaxel injection

Docetaxel injection 75mg / m² IV every 3 weeks of each 21-day cycle.

Trial Locations (45)

100038

Beijing Shijitan Hospital Affiliated to Capital Medical University, Beijing

100048

The Sixth Medical Center of PLA General Hospital, Beijing

100144

Peking University Shougang Hospital, Beijing

101100

Beijing Luhe Hospital Capital Medical University, Beijing

102218

Beijing Tsinghua Changgung Hospital, Beijing

110042

Liaoning Cancar Hospital, Shenyang

150040

Harbin Medical University Cancer Hospital, Harbin

200080

Shanghai General Hospital, Shanghai

210009

Jiangsu Cancer Hospital, Nanjing

210029

Jiangsu Province Hospital, Nanjing

214023

Wuxi People's Hospital, Wuxi

214062

Hospital of Jiangnan University, Wuxi

226361

Nantong Cancer Hospital, Nantong

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

250117

Shandong Cancer Hospital, Jinan

300050

Tianjin Medical University General Hospital, Tianjing

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjing

330006

The First Affiliated Hospital of Nanchang University, Nanchang

350011

Fujian Provincial Cancer Hospital, Fuzhou

361003

The First Affiliated Hospital of Xiamen University, Xiamen

361004

Zhongshan Hospital Xiamen University, Xiamen

362000

Quanzhou First Hospital, Quanzhou

The Second Affiliated Hospital of Fujian Medical University, Quanzhou

410008

Xiangya Hospital Central South University, Changsha

410011

The Second Xiangya Hospital of Central South University, Changsha

410013

Hunan Cancer Hospital, Changsha

430022

Union Hospital,Tongji Medical College,Huazhong University of Science and Technology, Wuhan

430030

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan

430079

Hubei Cancer Hospital, Wuhan

450003

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

450008

Henan Cancer Hospital, Zhengzhou

453000

Xinxiang Central Hospital, Xinxiang

455000

AnYang Tumor Hospital, Anyang

510000

Sun Yat-Sen University Cancer Center, Guangzhou

510610

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou

524000

Affiliated Hospital of Guangdong Medical University, Zhanjiang

530021

Guangxi Medical University Affiliated Tumor Hospital, Nanning

710004

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi’an

710061

First Affiliated Hospital of Xi'an Jiaotong University, Xi’an

730000

The First Hospital of Lanzhou University, Lanzhou

733000

Gansu Wuwei Tumour Hospital, Wuwei

750021

People's Hospital of Ningxia Hui Autonomous Region, Yinchuan

844000

The First People's Hospital of kashi region, Kashgar

050010

The Fourth Hospital of Hebei Medical University, Shijiazhuang

030013

Shanxi Provincial Cancer Hospital, Taiyuan

All Listed Sponsors
lead

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY