NCT05270824

Study Evaluating Neoadjuvant Immunotherapy Increasing CD8+ Cell Infiltration in Advance Gastric Adenocarcinoma

Study Evaluating Neoadjuvant Immunotherapy Increasing CD8+ Cell Infiltration in Advance Gastric Adenocarcinoma : a Single Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Focusing on the clinical question of whether patients with advanced gastric cancer can benefit from immunotherapy, this project intends to detect the degree of CD8+ tumor-infiltrating lymphocyte infiltration in patients with advanced gastric cancer before and after receiving neoadjuvant combined immunotherapy and neoadjuvant therapy alone. To explore the evolving nature of tumor immune response before and after neoadjuvant therapy for gastric cancer, and quantitatively present it through chemical immunohistochemical techniques to achieve a more accurate diagnosis and treatment and improve the long-term efficacy of patients.

Conditions

• Advanced Gastric Carcinoma
• CD8+ Tumor Infiltrating Lymphocytes
• Neoadjuvant Immunotherapy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	radical surgery after neoadjuvant immunotherapy	A total or distal gastrectomy with D2 lymph node dissection was done depending on the tumor location after neoadjuvant immunotherapy.
COMBINATION_PRODUCT	radical surgery after neoadjuvant chemotherapy	A total or distal gastrectomy with D2 lymph node dissection was done depending on the tumor location after neoadjuvant immunotherapy.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-03-01
• Completion: 2027-03-01
• First posted: 2022-03-08
• Last updated: 2022-03-08