Neoadjuvant Treatment With Tislelizumab Plus LM-302 and S-1 or Tislelizumab Plus SOX for Claudin 18.2-Positive Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

This trial investigates treatments for patients with Claudin 18.2-positive locally advanced gastric or gastroesophageal junction adenocarcinoma. Researchers are comparing two neoadjuvant therapy combinations to evaluate their effects one combines Tislelizumab with LM-302 and S-1, and the other combines Tislelizumab with SOX. The study is designed as a Phase 2, randomized, exploratory trial to understand the outcomes of these treatments in this specific cancer type. Participants receive either Tislelizumab 200mg with LM-302 2.0mgkg through intravenous infusion on day 1 along with oral S-1 dosed by body surface area twice daily for 14 days every 3 weeks, or Tislelizumab 200mg with oxaliplatin 130 mgm2 intravenous infusion plus oral S-1 following the same dosing schedule. The treatments are given before surgery in a neoadjuvant setting to assess their impact on the tumor. Throughout the study, participants will be monitored for pathological complete response rates over 24 months, along with treatment-related adverse events, major pathological response, R0 resection rates, event-free survival, and overall survival up to 36 months. The trial involves regular assessments including imaging and clinical evaluations to track effectiveness and safety. The total duration of follow-up will extend to three years to assess long-term outcomes and survival.

Neoadjuvant Tislelizumab + LM-302 + S-1 or Tislelizumab + SOX for CLDN18.2-Positive Gastric/GEJ Adenocarcinoma