Phase 3 Study of Definitive Chemoradiotherapy With or Without Immunotherapy for Unresectable Esophageal or Esophagogastric Junction Cancer

What this Trial Is About

Researchers are investigating treatment options for patients with unresectable esophageal or esophagogastric junction cancer. This study aims to explore the best ways to combine chemoradiotherapy with immunotherapy or targeted drugs, such as PD-1PD-L1 antibodies, to improve outcomes. Molecular targeting agents have not yet shown clear benefits for this cancer, so the study focuses on newer cancer immunotherapies and how they might work with radiotherapy. Participants receive one of two treatments standard chemoradiotherapy alone or chemoradiotherapy combined with immunotherapy or targeted agents. Chemoradiotherapy includes radiation doses between 50-66 Gy over 25-30 fractions and chemotherapy with drugs such as platinum-based, paclitaxel-based, 5-FU analog-based chemotherapy, or nimotuzumab. Immunotherapy involves anti-PD-1PD-L1 antibodies. Treatments are tailored by the physicians preference, with chemotherapy given every 1 to 3 weeks and nimotuzumab dosed weekly. During the study, participants are closely monitored for overall survival at 1, 2, 3, and 5 years, as well as progression-free survival and treatment side effects. Researchers also assess tumor response and recurrence rates. The study involves follow-up evaluations to track acute and late toxicities, pathological responses, and surgical outcomes when applicable. The total duration of participation may extend over several years to capture long-term results.

Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer