JS107 in Combination With Toripalimab and Chemotherapy for the Treatment of CLDN18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

This study is a multicenter, randomized, open-label, controlled Phase III clinical trial aimed at evaluating the efficacy and safety of JS107 combined with toripalimab XELOX versus sintilimab combined with XELOX as first-line treatment for patients with advanced G/GEJ adenocarcinoma. The research subjects were patients with unresectable locally advanced, recurrent or metastatic G/GEJ adenocarcinoma who were CLDN18.2-positive and HER2-negative and had not received systemic treatment before (except for neoadjuvant/adjuvant therapy that occurred more than 6 months after disease progression/recurrence from the last treatment). The study took BICR-PFS and OS as Dual primary endpoints.

NCT Number	NCT07584135
Lead Sponsor	NingBo Junyan Hongshi Biosciences Co., Ltd
Conditions	Gastric Adenocarcinoma
Enrollment	600 participants
Start Date	2026-05-28
Primary Completion	2029-01-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-29