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An Open Label, Single Arm, Multicenter Phase Ⅰb/Ⅱ Clinical Study of Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
This is a prospective, open-label, multicenter, single arm phase Ⅰb/Ⅱ clinical study aims to explore the efficacy and safety of fruquintinib combined with toripalimab and SOX regimen in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.
Details
| Lead sponsor | The First Affiliated Hospital of Zhengzhou University |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 64 |
| Start date | 2022-06-01 |
| Completion | 2025-02 |
Conditions
- Metastatic Gastric Cancer
Interventions
- fruquintinib＋toripalimab + SOX
Primary outcomes
- DLTs — At the end of Cycle 1 (each cycle is 28 days)
DLTs are defined as grade 3 or higher adverse events that are related to fruquintinib during the first cycle of therapy. - RP2D — At the end of Cycle 1 (each cycle is 28 days)
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) - PFS — about 2 years
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Countries
China