Phase Ib Study of Tislelizumab Combined with Extended FLOT Chemotherapy Before Surgery for Locally Advanced Resectable Esophagogastric Adenocarcinoma

What this Trial Is About

Researchers are evaluating a new combination therapy using tislelizumab and FLOT chemotherapy given before surgery neoadjuvant for patients with locally advanced, resectable adenocarcinoma of the esophagus or stomach. This phase Ib trial aims to determine if this combination is safe and active enough to support further studies of new drug combinations in this setting. The study also explores extending preoperative chemotherapy cycles to improve patient tolerance compared to the usual pre- and postoperative schedule. The treatment involves two dose levels in a dose intensification phase Dose level 1 includes 4 cycles of tislelizumab 200 mg intravenously every 3 weeks combined with 6 cycles of FLOT chemotherapy docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil intravenously every 2 weeks. Dose level 2 increases to 5 cycles of tislelizumab plus 8 cycles of FLOT. The optimal dose level, where side effects are acceptable, will then be expanded with additional patients. The study focuses on giving more cycles before surgery to assess safety and potential clinical activity. Participants will be monitored closely during treatment for side effects and effectiveness, with assessments including physical exams, blood tests, and imaging. Researchers will measure the feasibility of delivering up to 8 months of this combined therapy before surgery. The trial will also involve checking tumor tissue for specific markers to guide treatment evaluation. The total duration includes the treatment phase and follow-up to assess patient outcomes and safety.

A Phase Ib Trial Evaluating the Safety and Activity of Neoadjuvant Combination of Tislelizumab Plus FLOT for Resectable Esophagogastric Adenocarcinoma