Trials / Active Not Recruiting
Active Not RecruitingNCT04950322
A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
A Randomized, Double-Blind, Multi-Center, Phase III Clinical Study of SHR-1701 Plus Chemotherapy Versus Placebo Plus Chemotherapy as Treatment in Patients With Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 737 (actual)
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. For Part 1 study，the tolerability of SHR-1701 will be evaluated and determine the recommended dose for Part 2.For Part 2 study, all enrolled patients will be randomized to 2 groups and continuously treated until the end criteria of treatment was met.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1701、CAPOX | SHR-1701 with CAPOX (CAPOX:Oxaliplatin,Capecitabine) |
| DRUG | Placebo、CAPOX | Placebo with CAPOX (CAPOX:Oxaliplatin,Capecitabine) |
Timeline
- Start date
- 2021-12-06
- Primary completion
- 2024-05-20
- Completion
- 2025-10-01
- First posted
- 2021-07-06
- Last updated
- 2025-03-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04950322. Inclusion in this directory is not an endorsement.