First-line Treatment with Fruquintinib, Trastuzumab, and XELOX in Adults Aged 18 to 75 with HER2-positive Advanced Gastric or Gastroesophageal Junction Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining fruquintinib with trastuzumab and XELOX chemotherapy as a first treatment for patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. This open-label, single-center study includes patients aged 18 to 75 years with no previous treatment for metastatic disease, aiming to find the recommended doses and measure progression-free survival. Participants receive fruquintinib in escalating doses during phase Ib, along with a XELOX regimen consisting of oxaliplatin and capecitabine, plus trastuzumab given intravenously every three weeks. After 6-8 cycles of this combination, patients continue on maintenance therapy with trastuzumab, fruquintinib, and capecitabine until disease progression, death, or intolerable side effects. Throughout the study, patients will have regular assessments including tumor measurements to monitor response, safety evaluations, and laboratory tests. The primary outcomes include determining the recommended phase 2 doses after the first treatment cycle and progression-free survival over up to three years. Secondary outcomes like overall survival and tumor response rates will also be tracked. The total involvement may last up to three years with ongoing monitoring.

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