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

Metastatic Gastroesophageal Junction Adenocarcinoma Clinical Trial

Official title:
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)

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06329973
Study type Interventional
Source Henan Cancer Hospital
Contact Xiaobing Chen
Phone +8613937100233
Email zlyychenxb0807@zzu.edu.cn
Status Recruiting
Phase Phase 1/Phase 2
Start date February 28, 2024
Completion date February 15, 2028
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