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.
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;
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;
Single group
fruquintinib + tislelizumab + FOLFOX
Drugphase Ib: fruquintinib (3+3 dose escalation design): L1: 3 mg/d, L2: 4 mg/d, L3: 5 mg/d, qd po, D1-14, Q3W; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin : 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W. phase II: fruquintinib: RP2D; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin: 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W.
Phase Ib: Maximum tolerated dose (MTD)
Maximum Tolerated Dose (MTD) of fruquintinib. Investigators leading the study will find the maximum tolerated dose by assessing the rate of serious side effects (known as "dose limiting toxicities") among participants according to the CTCAE 5.0.
Phase Ib: RD
To determine the recommended phase 2 dose of fruquintinib, according to the dose limiting toxicities (DLTs).
Six-month progression-free survival
The proportion of patients who remain alive and free from disease progression for at least 6 months after initiating treatment.
PFS
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
OS
OS is defined as the time from the date of randomization to the date of death due to any cause.
ORR
ORR is defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) per RESISTv1.1.
DCR
DCR is defined as the percentage of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD) per RESISTv1.1.
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