Safety and Preliminary Effectiveness of XH001 Injection Combined With Tumor-Specific T-Cell Therapy in Adults With Advanced Gastric Cancer

What this Trial Is About

Researchers are studying the safety and preliminary effectiveness of a combined treatment using the tumor neoantigen vaccine called XH001 and neoantigen vaccine-induced tumor-specific T-cell injections for adults with advanced gastric cancer. This phase 1 clinical trial focuses on understanding potential medical problems from this combination therapy and whether it can shrink tumors or extend survival. Participants receive two doses of the XH001 injection at 400 micrograms each, along with two doses of tumor-specific T-cell injections. This study is non-randomized and open-label, meaning all participants receive the combined treatment. The trial aims to monitor participants for safety, tolerance, and early signs of the treatment working against cancer. During the study, researchers will track side effects and dose-related toxicities for up to 12 months after treatment. They will also evaluate tumor response, disease control, progression-free survival, overall survival, and duration of response over periods ranging from 24 to 36 months. Participants will undergo regular evaluations including imaging to measure tumor size and health assessments to monitor treatment effects and safety throughout the study period.

Clinical Trial on the Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastric Cancer