This study was designed to evaluate the safety and efficacy of fruquintinib plus trastuzumab, and XELOX as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Have fully understood the study and voluntarily signed the informed consent;
18-75 years old (including 18 and 75 years old);
Pathologically determined advanced gastric or gastroesophageal junction adenocarcinoma;
No previous anti-tumor treatment for metastatic diseases;
Failure to comply with the study protocol or study procedure;
Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors, chemotherapy or immune checkpoint inhibitors;
Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
Known presence of symptomatic central nervous system metastasis or brain metastases;
Single group
fruquintinib＋trastuzumab + XELOX
Drugphase Ib: fruquintinib (3+3 dose escalation design): L1: 2 mg/d, L2: 3 mg/d, L3: 4 mg/d, qd po, D1-14, Q3W; XELOX regimen: Oxaliplatin: 130mg/m2, ivgtt 2h, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; trastuzumab: 8 mg/kg loading dose and then 6 mg/kg maintenance dose, IV, D1, Q3W; phase II: fruquintinib: RP2D; XELOX regimen: Oxaliplatin: 130mg/m2, ivgtt 2h, D1, Q3W; Capecitabine: 1000 mg/m2, bid, D1-D14, Q3W; trastuzumab: 8 mg/kg loading dose and then 6 mg/kg maintenance dose, IV, D1, Q3W. After 6-8 cycles of combination therapy, trastuzumab plus fruquintinib plus capecitabine was given as maintenance therapy until disease progression, death or intolerable toxicity.
Recommended Phase 2 doses (RP2Ds)
To determine the recommended phase 2 dose of fruquintinib, according to the dose limiting toxicities (DLTs).
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.
Exploratory endpoints
To investigate the correlations between PD-L1, CD-47B, HER2 expression and immune cell infiltration with clinical outcomes.
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