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Lymph Node Metastasis Pattern After Neoadjuvant Chemoimmunotherapy in LAGC
Sponsor: Hainan General Hospital
Summary
The purpose of this observational study is to learn how stomach cancer that has spread to nearby lymph nodes responds to standard chemotherapy combined with immunotherapy given before surgery. In people with locally advanced gastric cancer, this pre-surgery treatment can shrink the tumor and clear cancer cells from some lymph nodes. However, it is not clear which groups of lymph nodes around the stomach still contain cancer cells after treatment. The study will also examine whether dense scarring (fibrosis) around the tumor is linked to a lower chance of cancer remaining in the lymph nodes. This information may help doctors in the future decide whether some lymph node groups can be safely left in place during surgery for people with severe scarring. Participants in this study will receive standard pre-surgery treatment with SOX chemotherapy (S-1 plus oxaliplatin) and a PD-1 inhibitor for at least 2 cycles. After treatment, they will undergo standard gastrectomy with D2 lymph node dissection, which is the routine surgical removal of the main lymph node groups around the stomach. During surgery, the surgeon will record the degree of scarring and difficulty in separating the tissues. Lymph nodes will be collected and labeled by station so that each group can be examined separately. The study will then describe how often cancer is found in each lymph node station after treatment and explore whether scarring is related to cancer remaining in the nodes. The study will also track surgical outcomes and follow participants for up to 3 years to assess cancer recurrence and survival. Approximately 103 participants will be enrolled. The study is expected to run from January 2027 through December 2029. Each participant will be followed for about 3 years after surgery, with clinic visits every 3 months for the first 2 years and every 6 months in the third year. This study does not assign participants to different treatments; all participants receive standard care, and the study only observes and records the results.
Official title: A Prospective Multicenter Study on the Patterns and Clinical Significance of Lymph Node Metastasis in Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy Combined With Immunotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
103
Start Date
2027-01-01
Completion Date
2029-12-31
Last Updated
2026-10-28
Healthy Volunteers
No
Interventions
Neoadjuvant SOX chemotherapy combined with PD-1 inhibitor
1\. Intervention Name: SOX regimen (S-1 and Oxaliplatin) Intervention Description: Patients will receive the standard SOX chemotherapy regimen, consisting of S-1 and oxaliplatin, as part of their neoadjuvant treatment. The treatment will be administered in clinical routine for a minimum of two cycles prior to surgery. 2. Intervention Name: Anti-PD-1 inhibitor Intervention Description: Patients will receive an anti-PD-1 inhibitor (which may include Toripalimab, Sintilimab, Tislelizumab, or Nivolumab) in combination with the SOX chemotherapy regimen as part of their neoadjuvant treatment. This immunotherapy will be administered for a minimum of two cycles prior to surgery. 3. Intervention Name: D2 radical gastrectomy Intervention Description: Following the completion of neoadjuvant therapy, patients will undergo a standard distal or total gastrectomy with D2 lymph node dissection. During the procedure, surgeons will objectively assess local tissue edema and fibrosis. Post-resection, t