Phase IbII Study of Capeox Combined With Sintilimab and Bevacizumab as First Treatment for Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are studying advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction, focusing on patients who have not yet received systemic treatment. The study evaluates the combination of the Capeox chemotherapy regimen with the immunotherapy drug sintilimab and the targeted therapy bevacizumab. This phase IbII clinical trial aims to explore the safety, appropriate dose, and response rate of this combination as a first-line treatment for recurrent or metastatic gastric cancer, addressing the current limitations of standard chemotherapy whose median survival time is about one year. The treatment involves two stages Stage Ib includes oxaliplatin, capecitabine tablets, sintilimab, and bevacizumab Stage II uses bevacizumab at a dose determined in Stage Ib, while the other drugs continue at the same dosage. Participants receive this combination therapy without a comparison group since it is a one-arm, open-label study. The study also assesses the best dose of bevacizumab and monitors treatment response and disease control over time. Participants will undergo regular evaluations including imaging to measure lesion response, laboratory tests to check organ function and blood counts, and pregnancy testing for females of childbearing age. The main outcomes measured are the appropriate bevacizumab dose within 1.5 to 3 months and the objective response rate over two years. Secondary outcomes include progression-free survival, overall survival, and disease control rate monitored between one and three years. The total duration of participation varies, and patients are monitored closely for safety and treatment effects throughout the study.

Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer