Trials / Completed
CompletedNCT03472365
A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer
A Randomized Phase 2 Study to Evaluate Safety and Efficacy of the Combination of SHR-1210 With Capecitabine + Oxaliplatin or Apatinib as First-line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Detailed description
Approximately 110 participants will be assigned to SHR-1210 + capecitabine + oxaliplatin combination therapy (Cohort 1), or SHR-1210 + apatinib combination therapy (Cohort 2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SHR-1210 | SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody |
| 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 | 375 mg administered as continuous oral once daily (QD) of each 3-week cycle. |
Timeline
- Start date
- 2018-04-02
- Primary completion
- 2020-11-25
- Completion
- 2020-11-25
- First posted
- 2018-03-21
- Last updated
- 2024-01-11
- Results posted
- 2024-01-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03472365. Inclusion in this directory is not an endorsement.