Phase III Study to Test Safety of Irinotecan and POF Paclitaxel, Oxaliplatin, 5-fluorouracil, Leucovorin with Tislelizumab for Advanced Gastric Cancer

What this Trial Is About

Researchers are evaluating the safety of a combination treatment involving Irinotecan and paclitaxel with 5-fluorouracil, leucovorin, oxaliplatin, and Tislelizumab for patients with advanced unresectable gastric or gastroesophageal junction adenocarcinoma. This phase III study aims to determine the maximum dose patients can tolerate and assess the overall response, progression-free survival, and overall survival over two years. The treatment regimen includes sequential dosing of Irinotecan and paclitaxel at increasing levels on day 1 of each 14-day cycle. Oxaliplatin and Levo-leucovorin are given on day 1, followed by a 46-hour infusion of 5-fluorouracil using an ambulatory pump. Tislelizumab is administered at a fixed dose every 14 days. Dose-limiting toxicities are monitored during the first four weeks to guide dose escalation, with specific criteria to define when to stop increasing doses. Participants will receive regular treatments every two weeks and undergo monitoring for safety and treatment response. Researchers will evaluate the maximum tolerated dose after one month and follow patients for up to two years to track treatment outcomes. Safety assessments include blood tests, organ function tests, and performance status evaluations. The total study duration spans from the start date until the planned end date in late 2025.

Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab