Phase III Trial of Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor Maintenance in Adults with Locally Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating whether combining chemoradiotherapy with immunotherapy as a maintenance treatment can help treat adults with locally advanced esophageal squamous cell cancer. This Phase III trial aims to understand the effectiveness of this approach compared to standard treatments. The study focuses on patients with specific stages of this cancer confirmed by histology and classified by the 8th UICC-TNM system. Participants are randomly assigned to one of four groups unlimited radiotherapy with PD-1 inhibitor maintenance therapy, unlimited radiotherapy with surveillance, tumor-draining lymph node-sparing radiotherapy with PD-1 inhibitor maintenance therapy, or tumor-draining lymph node-sparing radiotherapy with surveillance. The PD-1 inhibitor is given intravenously at a fixed dose of 200 mg every three weeks for one year after radiotherapy. Chemotherapy with paclitaxel and cisplatin is also part of the treatment. Radiotherapy is delivered at a dose of 50.4 Gy across 28 fractions. During the study, participants will undergo regular assessments to monitor progression-free survival over two years, overall survival, and adverse events related to the treatments. Safety and organ function tests will be conducted, and researchers will closely observe treatment effects and side effects. The study lasts at least two years, including follow-up to track outcomes and safety.

CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC