Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
NCT06459921 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-10-10
Summary
This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.
Conditions
- Neoadjuvant Chemotherapy
- Sintilimab
- Locally Advanced Gastric Cancer
Interventions
- DRUG
-
SOX+Sintilimab
Patients would be allocated to the SOX+Sintilimab group.
- DRUG
-
FLOT+Sintilimab
Patients would be allocated to the FLOT+Sintilimab group.
Sponsors & Collaborators
-
Xijing Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-01
- Primary Completion
- 2026-07-01
- Completion
- 2028-12-31
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