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

NCT03745170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2023-03-01

No results posted yet for this study

Summary

The purpose of this study is to estimate overall survival of Sintilimab+ oxaliplatin + capecitabine and placebo+ oxaliplatin + capecitabine, as first-line treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Conditions

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

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2021-06-20
Completion
2022-10-21

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745170 on ClinicalTrials.gov