Study of Fruquintinib Combined With Sintilimab and CAPEOX as First Treatment for Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction Cancer

What this Trial Is About

Researchers are studying a first-line treatment combining fruquintinib, sintilimab, and CAPEOX chemotherapy for adults with unresectable or postoperative recurrent advanced gastric or gastroesophageal junction adenocarcinoma. This single-arm, open-label Phase IbII trial aims to assess the safety and effectiveness of this combination, exploring its impact on tumor immune response and vascular normalization. The study also investigates molecular markers and tumor changes to better understand and improve treatment outcomes. Participants receive varying doses of fruquintinib combined with the PD-1 inhibitor sintilimab and CAPEOX chemotherapy, which includes oxaliplatin and capecitabine. The trial evaluates the best dose of fruquintinib during the first 21 days and continues treatment as part of the comprehensive plan. This approach is designed to enhance chemotherapy delivery and reactivate the bodys immune response against the tumor. During the study, participants undergo regular assessments including measurement of tumor response, survival rates, progression, and side effects over up to 48 months. Researchers will monitor treatment safety up to 30 days after the last dose and analyze molecular biomarkers related to treatment effects. Participants organ function, tumor changes, and overall health status are closely followed to evaluate the therapys impact and identify potential benefits.

Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer