CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 650 enrolled
Drug / intervention
Sintilimab +3 moredrug
Likely dose
Sintilimab 3mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03745170
NCT03745170Phase 3Completed
CompareCT.gov

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

Innovent Biologics (Suzhou) Co. Ltd.·interventional·Posted Nov 19, 2018·Updated Mar 1, 2023

In Brief

A Phase 3 clinical trial evaluating Sintilimab, Oxaliplatin, and 2 other interventions for Gastric Cancer. Completed, enrolled 650 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 19, 2018
Enrollment StartDec 19, 2018
Primary CompletionJun 20, 2021
Study CompletionOct 21, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.6 years ago

Interventions

Sintilimabdrug

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

Oxaliplatindrug

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

Capecitabinedrug

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

placebodrug

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