Study of Anti-PD-1, Capecitabine, and Oxaliplatin as First Treatment for dMMR Esophagogastric Cancer

What this Trial Is About

Researchers are studying the effects of combining two chemotherapy drugs with immunostimulants in patients with previously untreated metastatic or locally advanced esophagogastric cancer. This study focuses on how these treatments affect interferon gamma expression and the presence of cytotoxic T cells in the tumor environment. It is a phase 2, open-label study enrolling 25 patients with this specific cancer type who have not received prior chemotherapy or radiotherapy for their metastatic or irresectable disease. Participants receive two cycles of chemotherapy with capecitabine and oxaliplatin, each cycle lasting three weeks. After chemotherapy, they receive retifanlimab immunotherapy every four weeks for up to two years. The chemotherapy is given by mouth and intravenously, while retifanlimab is administered intravenously. The study includes collection of biopsies, blood, and feces samples during treatment to analyze immune cell infiltration and interferon gamma expression. During the study, patients undergo CT scans before and after chemotherapy and after 2-3 cycles of immunotherapy to evaluate tumor response. Researchers monitor immune activity in the tumor, overall survival, progression-free survival, response rates, adverse events, and patient-reported outcomes over periods up to 60 months. Safety and treatment effects are carefully assessed throughout the study, with treatment lasting up to two years and follow-up continuing for several years.

Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)