Trials / Completed
CompletedNCT03813784
A Clinical Study To Evaluate Camrelizumab (SHR-1210) Plus Capecitabine and Oxaliplatin Followed by Sequential Treatment With Camrelizumab Plus Apatinib Mesylate in Advanced or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJ) Without Prior Systemic Therapy
A Randomized, Open-label, Multi-center Phase III Clinical Study To Evaluate Camrelizumab (SHR-1210) Plus Capecitabine and Oxaliplatin Followed by Sequential Treatment With Camrelizumab Plus Apatinib Mesylate in Advanced or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJ) Without Prior Systemic Therapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 885 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, open-label, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus capecitabine and oxaliplatin sequenced by SHR-1210 plus apatinib versus capecitabine and oxaliplatin as first-line therapy in patients with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1210 | Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial |
| DRUG | Capecitabine | 1000 mg/m\^2 administered as continuous oral twice daily (BID) of each 3-week cycle. |
| DRUG | Oxaliplatin | 130 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle. |
| DRUG | Apatinib | 250 mg administered as continuous oral once daily (QD) of each 3-week cycle. |
Timeline
- Start date
- 2019-03-07
- Primary completion
- 2023-06-07
- Completion
- 2023-06-07
- First posted
- 2019-01-23
- Last updated
- 2025-09-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03813784. Inclusion in this directory is not an endorsement.