About this trial
This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Eligibility criteria
Qualifiers
18-75 years old (including 18 and 75 years old);
Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
Pathologically determined gastric or gastroesophageal junction adenocarcinoma;
Advanced patients with radiographic confirmation of inoperable complete resection;
Disqualifiers
Patients who had received any drug in the study protocol in the last year;
Deficient mismatch repair (dMMR) or MSI-H detected by genetic test;
HER2 positive(HER-2 3+, or HER-2 2+ and FISH+);
Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
Trial design
Treatments tested in this trial
- fruquintinib + tislelizumab + FOLFOX
Treatment groups
Locations
1Sponsors and collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Lead sponsor