Phase 2 Study of Propranolol Added to Pembrolizumab and Standard Chemotherapy for Advanced Unresectable or Metastatic Esophageal and Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are studying patients with unresectable locally advanced or metastatic esophageal or gastroesophageal junction adenocarcinoma, which cannot be removed by surgery or has spread to other parts of the body. This phase II trial evaluates the effects of adding propranolol, a beta-blocker, to pembrolizumab immunotherapy and standard chemotherapy mFOLFOX to see if it improves treatment response. The study also explores how stress-related hormones might impact cancer treatment effectiveness. Participants receive a combination of treatments including mFOLFOX6 chemotherapy drugs leucovorin, oxaliplatin, and fluorouracil given intravenously, pembrolizumab immunotherapy given intravenously, and propranolol taken orally. Before starting treatment, patients undergo a tumor biopsy. During the study, they have CT scans and blood samples collected to monitor their condition and treatment effects. Throughout the trial, researchers assess the overall response rate within six months of starting treatment. They also monitor progression-free survival, overall survival, and safety for up to two years. Patients complete stress questionnaires, and researchers study changes in biomarkers and immune cells. Safety is checked through regular evaluations, and participation may last up to two years depending on treatment and disease progression.

Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma