Trials / Completed
CompletedNCT03745170
Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 650 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-12-19
- Primary completion
- 2021-06-20
- Completion
- 2022-10-21
- First posted
- 2018-11-19
- Last updated
- 2023-03-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03745170. Inclusion in this directory is not an endorsement.