NCT03745170View on ClinicalTrials.gov

Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer

PHASE3CompletedINTERVENTIONAL

Enrollment

650

Participants

Timeline

Start Date

December 19, 2018

Primary Completion Date

June 20, 2021

Study Completion Date

October 21, 2022

Conditions

Gastric Cancer

Interventions

DRUG

Sintilimab

Weight\<60Kg: 3mg/kg Q3W Weignt\>=60Kg:200 mg Q3W on Day 1 by IV infusion

DRUG

Oxaliplatin

130 mg/m\^2 Q3W on Day 1 by IV infusion

DRUG

Capecitabine

1000 mg/m\^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14

DRUG

placebo

Weight\<60Kg: 3mg/kg Q3W Weignt\>=60Kg:200 mg Q3W on Day 1 by IV infusion

Trial Locations (1)

100000

The Fifth Medical Center,Chinese PLA General Hospital, Beijing

All Listed Sponsors

lead

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

NCT03745170 - Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer | Biotech Hunter | Biotech Hunter