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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 (Jun 2026). This Phase 1/2 trial studies fruquintinib+trastuzumab + XELOX for gastric adenocarcinoma.

Phase 1/2RecruitingHenan Cancer HospitalNCT07334431Data as of Jun 2026Location: China

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

Treatments studied

Targeted therapy

fruquintinib+trastuzumab + XELOX

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT07334431 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ERBB2?

Yes, ERBB2 positive is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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