Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

April 30, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Gastric Cancer
Interventions
DRUG

Experimental dose: modified XELOX + sintilimab

The treatment option for the modified XELOX group (study group) is 200 mg of sintilimab IV Drip Q3W, 600 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 78 mg/m2 IV Drip Q3W.

DRUG

Standard dose: standard XELOX + sintilimab

The treatment option for the standard XELOX group (control group) is 200 mg of sintilimab IV Drip Q3W, 1000 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 130 mg/m2 IV Drip Q3W.

Trial Locations (10)

430030

NOT_YET_RECRUITING

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

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

Unknown

RECRUITING

The Affliated Cancer Hospital of Guizhou Medical University, Guiyang

NOT_YET_RECRUITING

Harbin Medical University Cancer Hospital, Harbin

NOT_YET_RECRUITING

Henan Cancer Hospital, Zhengzhou

NOT_YET_RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

RECRUITING

The Second Hospital of Dalian Medical University, Dalian

NOT_YET_RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

NOT_YET_RECRUITING

West China Hospital of Sichuan University, Chengdu

NOT_YET_RECRUITING

The Second Affiliated Hospital of Kunming Medical University, Kunming

All Listed Sponsors
lead

Sun Yat-sen University

OTHER