Phase II Study of Perioperative Chemotherapy with FLOT, Trastuzumab, and Toripalimab in HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma

What this Trial Is About

Researchers are evaluating a combination treatment for people with HER2-positive locally advanced gastric or esophagogastric junction adenocarcinoma. This phase II clinical trial aims to assess the safety and effectiveness of perioperative chemotherapy using the FLOT regimen with trastuzumab and toripalimab. The study focuses on participants with resectable tumors to improve treatment outcomes before and after surgery. The treatment involves giving toripalimab as an intravenous infusion every 21 days for three cycles before surgery and three cycles after surgery. Trastuzumab is administered intravenously with a loading dose followed by maintenance doses on the same schedule. The chemotherapy drugs in the FLOT regimendocetaxel, oxaliplatin, leucovorin, and 5-fluorouracilare given in cycles every 14 days, with four cycles before surgery and four after. This combined regimen is studied across multiple centers. Participants will be closely monitored from enrollment through surgery and follow-up for up to 60 months. Researchers will evaluate the rate of complete tumor response after preoperative treatment, overall survival, progression-free survival, and types of side effects during and after therapy. Assessments include pathology, imaging, blood tests, and biopsies, along with regular safety checks. The study expects participants to provide samples for biomarker analysis and to undergo comprehensive health evaluations throughout the trial period.

Perioperative Chemotherapy Plus Trastuzumab Plus Toripalimab in HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma