Evaluating Radiotherapy Combined with CAPOX Chemotherapy and SHR-1701 Antibody for Unresectable Advanced Gastric or Gastroesophageal Junction Cancer

What this Trial Is About

Gastric cancer is a leading cause of cancer-related death worldwide, particularly in patients with unresectable locally advanced or metastatic disease who have a poor outlook. This trial evaluates the safety and effectiveness of combining radiotherapy with CAPOX chemotherapy and SHR-1701, a PD-L1TGF- bispecific antibody, in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. The goal is to improve local tumor control and systemic anti-tumor effects to increase the chances of curative surgery and improve survival outcomes. Participants will receive induction treatment with CAPOX plus SHR-1701, followed by radiotherapy targeting the primary tumor and metastatic lesions along with additional CAPOX plus SHR-1701 therapy. Those who become eligible may undergo surgery aimed at cure, followed by SHR-1701 maintenance therapy as appropriate. Radiotherapy doses are tailored based on tumor location and size, and SHR-1701 is administered intravenously every 21 days. Throughout the study, participants will be monitored for progression-free survival up to 12 months, with secondary evaluations including response rates, overall survival, local control, pathological responses, adverse events, and quality of life over up to 3 years. Biomarker analyses will also be conducted to explore treatment response factors. The study involves multiple assessments including lab tests, imaging, and clinical evaluations to track safety and effectiveness during treatment and follow-up.

Chemoradiotherapy and SHR-1701 in Patients With Unresectable Gastric Cancer