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RecruitingPhase 1Phase 2NCT07334431

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

Sponsor

Henan Cancer Hospital

Enrollment

45 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Gastric (Stomach) CancerGastric AdenocarcinomaGEJ AdenocarcinomaHER2-positive Gastric Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of four treatments — fruquintinib (a targeted drug), trastuzumab (a HER2-targeting antibody), and XELOX chemotherapy (capecitabine plus oxaliplatin) — as first-line treatment for patients with advanced HER2-positive stomach or stomach-esophagus junction cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma (confirmed by biopsy) - You have not previously received treatment for metastatic disease - You have good overall health (ECOG 0–1) and life expectancy of at least 3 months - Your blood counts and organ function meet the required thresholds **You may NOT be eligible if...** - You have previously received VEGFR inhibitors, chemotherapy for metastatic disease, or other targeted treatments - You have cancer that has spread to the brain or spinal cord - You have significant heart or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGfruquintinib＋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.

Locations(1)

Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)

Zhengzhou, Henan, China

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NCT07334431

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