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

44 Participants
are divided into 1 treatment group

Locations

1
The Sixth Affiliated Hospital of Sun Yat-sen University210000, GuangzhouGuangdong, China

Sponsors and collaborators

Sixth Affiliated Hospital, Sun Yat-sen University

Lead sponsor