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Sintilimab Combined With Fruquintinib and Chemotherapy Versus Sintilimab and Chemotherapy for Conversion Therapy in Unresectable Stage IV Gastric Cancer: a National Multicenter Randomized Controlled Study
This is a multicenter, randomized, open-label, phase 2 clinical study aiming to evaluate the feasibility and efficacy of sintilimab (PD-1 inhibitor) in combination of fruquintinib and chemotherapy (S-1 plus nab-paclitaxel) versus sintilimab and chemotherapy as conversion therapy in patients with stage IV gastric cancer in China.
Details
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 158 |
| Start date | 2024-06 |
| Completion | 2027-06 |
Conditions
- Gastric Cancer
- Gastric Adenocarcinoma
- Gastroesophageal Junction Adenocarcinoma
Interventions
- Sintilimab + Fruquinitinib + S-1 plus nab-paclitaxel
- Sintilimab + S-1 plus nab-paclitaxel
Primary outcomes
- R0-surgery conversion rate — about 3 years
The proportion of patients who underwent R0 surgery among all efficacy evaluable patients.
Countries
China