NCT06329973

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

A Single-arm, Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Sintilimab and CAPEOX as 1L Treatment for Advanced Unresectable or Metastatic G/GEJ Cancer (FUNCTION Research)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies

Conditions

• Metastatic Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Fruquintinib in combination with Sintilimab and CAPEOX	Different doses of fruquintinib combined with sintilimab and CAPEOX

Timeline

• Start date: 2024-02-28
• Primary completion: 2026-06-28
• Completion: 2028-06-28
• First posted: 2024-03-26
• Last updated: 2025-07-17

Locations

1 site across 1 country: China