Efficacy and Safety of DVDMS-Photodynamic Therapy for Dysphagia in Advanced Esophageal Cancer: A Phase II Clinical Trial.

Photodynamic therapy (PDT) is a localized treatment for esophageal stenosis and dysphagia in advanced cancer. This study evaluated the efficacy and safety of Cosiporfin sodium (DVDMS)-mediated PDT for dysphagia in advanced esophageal cancer. In this Phase II trial, patients with advanced esophageal cancer and Grade ≥ 2 dysphagia, who were unsuitable for or declined curative therapies, received 0.2 mg/kg DVDMS followed by PDT (wavelength: 630 nm) at varying regimens: 102 J/cm (24 h post-injection), 200 J/cm (24 h), and 150 J/cm (18 h). Safety was the primary endpoint. The study enrolled 20 patients in the 102 J/cm 24 h group, 6 in the 200 J/cm 24 h group, and 4 in the 150 J/cm 18 h group. Two patients experienced dose-limiting toxicities: One upper abdominal pain (16.7%) in the 200 J/cm 24 h group and one non-cardiac chest pain (25.0%) in the 150 J/cm 18 h group. Common adverse events included non-cardiac chest pain (10.0%) related to DVDMS and non-cardiac chest pain (20.0%) and anemia (20.0%) related to PDT. The photosensitivity test showed that by day 4, 66.7% of patients tested negative, improving to 86.7% by day 7, and all patients were negative by day 28. The esophageal overall response rate was 40.0% on day 28. The median duration of esophageal response and median OS for all patients were 4.86 months (95% CI: 1.51-5.32) and 9.51 months (95% CI: 5.45-NE), respectively. DVDMS-mediated PDT demonstrates acceptable safety and sustained efficacy in improving esophageal stenosis and dysphagia in advanced esophageal cancer. Trial Registration: chictr.org.cn ChiCTR2000032829.