A Single-center, Non-randomized, Open-label Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastric Cancer.
The goal of this clinical trial is to learn the safety of tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell in treating advanced gastric cancer in adults. It will also learn if the combined treatment works to treat advanced gastric cancer. The main questions it aims to answer are: What medical problems do participants have when using the combined treatment? Does tumor neoantigen vaccine combined with neoantigen vaccine induced T-cell eliminate or shrink the tumor, and can it prolong the patient's survival period?
• Provision of signed and dated informed consent form.
• Aged between 18 and 70 years old, male or female.
• Advanced gastric cancer that has been diagnosed by histological and/or cellular pathology, and which has failed to respond to second-line standard treatment or is intolerant to it, or is not suitable for standard treatment at this stage.
• According to the RECIST 1.1 criteria for evaluating the efficacy of solid tumors, there must be at least one measurable lesion as the target lesion for efficacy evaluation. The total diameter of the overall tumor lesion (excluding bone metastases) should be ≤ 100mm, and the diameter of a single tumor lesion should be ≤ 30mm. If the lesion that has received local treatment (radiotherapy, ablation, vascular intervention, etc.) is the only lesion, then there must be clear imaging evidence of disease progression for this lesion.
• Expected survival duration ≥ 12 weeks.
• Adequate organ and bone marrow function.