Randomized Phase 2 Study of Adebrelimab with Famitinib and Irinotecan Versus Irinotecan Alone in Adults With Advanced Gastric or Gastroesophageal Junction Cancer After First-Line Treatment Failure

What this Trial Is About

Researchers are evaluating the combination of Adebrelimab with Famitinib and Irinotecan in patients with advanced gastric or gastroesophageal junction adenocarcinoma who have failed first-line systemic chemotherapy and immune checkpoint inhibitor treatments. This randomized, controlled, exploratory clinical trial aims to study the safety and effectiveness of this combination compared to Irinotecan alone. The study includes a safety run-in period followed by an extended treatment phase based on initial safety findings. During the initial safety run-in phase, 6 patients receive Adebrelimab combined with Famitinib and Irinotecan to monitor for dose-limiting toxicities over the first treatment cycle. If safety criteria are met, an additional 60 patients are randomized 11 into either the experimental group receiving Adebrelimab plus Famitinib and Irinotecan, or the control group receiving Irinotecan alone. Treatments are administered every three weeks and continued until disease progression, unacceptable toxicity, death, or withdrawal. Participants undergo regular assessments including evaluation of tumor response using RECIST v1.1 criteria and monitoring of adverse events for up to two years. The primary outcome is progression-free survival measured from enrollment to disease progression or death. Secondary outcomes include overall survival, disease control rate, and safety recorded through the study and 90 days post-treatment. Participants are followed closely with laboratory tests and clinical evaluations throughout the study period.

Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy