First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

Prospective Cohort Study on the Efficacy, Adverse Effects, and Biomarkers of First-Line/Neoadjuvant Therapy With Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Gastric Cancer

This prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes

Inclusion Criteria:

1. Age 18 years old or above
2. Patients with advanced gastric cancer or locally advanced gastric cancer
3. Have not received any previous anti-tumor therapy
4. Patients expected to receive immunotherapy for first-line or neoadjuvant therapy
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Adequate organ function

Exclusion Criteria:

1. Patients with contraindications to immunotherapy
2. Have received anti-tumor treatments such as immunotherapy and chemotherapy
3. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases
4. Severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment
5. History of allogeneic stem cell transplantation or organ transplantation