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OncoMatch/Clinical Trials/NCT07334431

Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer

Is NCT07334431 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies fruquintinib+trastuzumab + XELOX for gastric adenocarcinoma.

Phase 1/2RecruitingHenan Cancer HospitalNCT07334431Data as of May 2026

Treatment: fruquintinib+trastuzumab + XELOXThis 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.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Biomarker criteria

Required: HER2 (ERBB2) positive

HER2 positive

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: vegfr inhibitor

Cannot have received: chemotherapy

Cannot have received: immune checkpoint inhibitor

Lab requirements

Blood counts

Absolute neutrophil count ≥1.5×10^9/L; Platelet ≥100×10^9 /L; Hemoglobin ≥90g/L

Kidney function

Serum creatinine (Cr) <1.5×ULN; Endogenous creatinine clearance ≥50ml/min

Liver function

Total bilirubin < 1.5 ULN; ALT and/or AST < 1.5 ULN

Cardiac function

LVEF (Left ventricular Ejection Fraction) <50% or >50% excluded; NYHA >Level 2 excluded; severe/unstable angina, MI, CABG within 6 months excluded; ventricular arrhythmias requiring treatment excluded

The functions of vital organs met the following requirements... (see above for details); Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure >Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) <50% or >50% excluded

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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