Phase II Study Comparing Perioperative Disitamab Vedotin Plus Toripalimab and XELOX Versus Disitamab Vedotin Plus Toripalimab Versus XELOX in Patients With HER2-Positive Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of three perioperative treatment combinations for patients with HER2-expressing, locally advanced gastric or gastroesophageal junction adenocarcinoma. This phase II, open-label, randomized, multicenter trial compares Disitamab Vedotin plus Toripalimab and XELOX, Disitamab Vedotin plus Toripalimab, and XELOX alone to better understand their impact on this cancer type. The study involves three treatment groups one receiving the chemotherapy combination XELOX capecitabine and oxaliplatin, another receiving Disitamab Vedotin with Toripalimab, and a third group receiving all three treatments combined. Capecitabine is taken orally twice daily for 14 days every three weeks, oxaliplatin is given by intravenous infusion every three weeks, and Disitamab Vedotin and Toripalimab are administered intravenously every two weeks. Participants receive these treatments around the time of surgery. Participants will undergo assessments including pathological examinations to determine complete response rates, tumor regression, and surgical success, along with monitoring for adverse effects. The study will track outcomes such as remission rates, survival, and event-free survival for up to approximately two years. Evaluations include imaging and laboratory tests to monitor safety and treatment effects throughout the study period.

Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.