A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma

PHASE3CompletedINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

December 19, 2019

Primary Completion Date

October 7, 2022

Study Completion Date

October 7, 2022

Conditions
Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Interventions
DRUG

CS1001+ Fluorouracil+Cisplatin

"CS1001 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W).~Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle."

DRUG

Placebo+ Fluorouracil+Cisplatin

"Placebo 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W).~Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle."

Trial Locations (72)

201203

Shanghai East Hospital, Shanghai

Unknown

The First Affiliated Hospital of Bengbu Medical College, Bengbu

Anhui Provincial Hospital, Hefei

Hefei Second People's Hospital, Hefei

The First Affiliated Hospital of Anhui Medical University, Hefei

The Second Affiliated Hospital of Anhui Medical University, Hefei

Beijing Friendship Hospital, Capital Medical University, Beijing

Beijing Tsinghua Changgung Hospital, Beijing

Peaking University International Hospital, Beijing

Chongqing General Hospital, Chongqing

Special Medical Center of The People's Liberation Army of China, Chongqing

The First Affiliated Hospital of Chongqing Medical University, Chongqing

Fujian Cancer Hospital, Fuzhou

The First Affiliated Hospital of Xiamen University, Xiamen

The First People's Hospital of Foshan, Foshan

Cancer Center of Guangzhou Medical University, Guangzhou

Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou

Guangdong Provincial People's Hospital, Guangzhou

Jiangmen Central Hospital, Jiangmen

Jieyang People's Hospital, Jieyang

Affiliated Tumor Hospital of Shantou University Medical College, Shantou

The Fifth Affiliated Hospital of Sun Yat sen University, Zhuhai

Guangxi Medical University Affiliated Tumor Hospital, Nanning

Hainan General Hospital, Haikou

The Second Affiliated Hospital of Hainan Medical University, Haikou

Affiliated Hospital of Chengde Medical University, Chengde

Handan Central Hospital, Handan

Shijiazhuang People's Hospital, Shijiazhuang

The Affiliated Tumor Hospital of Harbin Meidical University, Haerbin

Anyang Cancer Hospital, Anyang

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang

Nanyang Central Hospital, Nanyang

Nanyang First People's Hospital, Nanyang

Puyang Oilfield General Hospital, Puyang

Xinxiang First People's Hospital, Xinxiang

Henan Cancer Hospital, Zhengzhou

Henan Provincial People's Hospital, Zhengzhou

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

Hubei Cancer Hospital, Wuhan

Tongji Medical College of HUST, Tongji Medical College Huazhong University of Science and Technology, Wuhan

Wuhan Fifth Hospital, Wuhan

Wuhan Union Hospital, Wuhan

Hunan Cancer Hospital, Changsha

Changzhou Tumor Hospital, Changzhou

Huai'an First People's Hospital, Huai'an

Jiangsu Province Hospital, Nanjing

Jiangxi Cancer Hospital, Nanchang

The First Affiliated Hospital Of Nanchang University, Nanchang

Jilin Cancer Hospital, Changchun

The Second Hospital of Jilin University, Changchun

Tonghua Central Hospital, Tonghua

Liaoning Cancer Hospital and Institute, Shenyang

Jinan central Hospital, Jinan

Shandong Cancer Hospital, Jinan

Linyi Cancer Hospital, Linyi

The Affiliated Hospital of Qingdao University, Qingdao

Shanghai Chest Hospital, Shanghai

Linfen Central Hospital, Linfen

Shanxi Provincial Cancer Hospital, Taiyuan

Chengdu Fifith people's hospital, Chengdu

Sichuan Provincial People's Hospital, Chengdu

West China Hospital Sichuan University, Chengdu

The Affiliated Hospital of Southwest Medical University, Luzhou

Suining Central Hospital, Suining

Yibin Second People's Hospital, Yibin

Tianjin Cancer Hospital, Tianjin

Tianjin Medical University General Hospital, Tianjin

Cancer Hospital Affiliated to Xinjiang Medical University, Ürümqi

Yunnan Cancer Hospital, Kunming

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

Zhejiang Cancer Hospital, Hangzhou

Zhejiang Provincial People's Hospital, Hangzhou

Sponsors
All Listed Sponsors
lead

CStone Pharmaceuticals

INDUSTRY

NCT04187352 - A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter