drugset / Trial / NCT05941481

Neoadjuvant Chemo-hypoRT Plus PD-1 Antibody (Tislelizumab) in Resectable LA-G/GEJ

NCT05941481 ↗

Phase 2 Completed 21 enrolled Jiangsu Cancer Institute & Hospital
NaSingle-groupOpen-labelTreatment

Summary

Gastric cancer is the third leading cause of death due to cancer worldwide. Although the consensus on the surgical treatment has resulted in the improvement of curative effect during the past decades, controversies remained for the perioperative therapy of gastric cancer, especially in the selection of the optimal neoadjuvant regimens. Immunotherapy with anti-programmed cell death-1 (PD-1) antibody has demonstrated moderate efficacy in selected patients with advanced gastric adenocarcinoma. Hypofractionated radiotherapy (HypoRT) may act synergistically with immunotherapy to enhance antitumor responses. This phase II trial study want to exploit the efficacy and safety to give PD-1 antibody (Tislelizumab) with combination chemotherapy and HypoRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.

Timeline

Start
2023-06-10
Primary completion
2025-03-15
Completion
2026-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 —
Subject Oxaliplatin Small molecule 130 mg/m2 —
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous