NCT07334431

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

Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: an Open-label, Single-arm, Single-center Phase Ib/II Clinical Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastric Adenocarcinoma
• Gastric (Stomach) Cancer
• GEJ Adenocarcinoma
• HER2-positive Gastric Cancer
• First-line Therapy
• Fruquintinib

Interventions

Type	Name	Description
DRUG	fruquintinib＋trastuzumab + XELOX	phase 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.

Timeline

• Start date: 2024-02-22
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: China