Phase II Study of Radiotherapy, Chemotherapy, and Anti-PD-1 Immunotherapy Followed by Surgery in Adults With Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combined treatment approach involving radiotherapy, chemotherapy, and anti-PD-1 immunotherapy followed by surgery for patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The study aims to determine if this multimodal treatment can improve survival and be safely performed in this patient group. This is a prospective, single-arm Phase II trial sponsored by Fudan University. Participants receive short course hypofractionated radiotherapy HFRT to the primary tumor and HFRT or stereotactic body radiotherapy SBRT to metastatic lesions. Systemic chemotherapy and anti-PD-1 immunotherapy are given concurrently. For HER2-positive patients, trastuzumab is added. Surgical removal of primary and metastatic lesions is performed when possible. If surgery is too invasive or not feasible, local ablative therapies like radiofrequency or microwave ablation may be used. Postoperative treatment includes chemotherapy and PD-1 antibody therapy continued up to one year after surgery. During the study, participants undergo treatment cycles involving radiotherapy, chemotherapy, immunotherapy, and surgery as planned. Researchers monitor overall survival over five years, along with disease progression, response rates, and surgical outcomes. Safety is assessed by tracking toxicities and complications during and after treatment. Follow-up includes regular evaluations and laboratory tests to assess treatment effects and patient health throughout the study period ending in 2027.

Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer