Phase II Study of High-Dose-Rate Esophageal Brachytherapy Combined with Radiotherapy, Chemotherapy, and Nivolumab for Locally Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating whether adding high-dose-rate HDR brachytherapy can improve outcomes for patients with locally advanced esophageal squamous cell carcinoma ESCC who have already received external beam radiotherapy EBRT, chemotherapy, and the immune therapy drug nivolumab. This phase II trial aims to see if HDR brachytherapy reduces the chance of cancer returning in the esophagus or nearby areas within 12 months and to assess safety and side effects when given after the other treatments. The study is sponsored by National Taiwan University Hospital and focuses on patients with stage III-IVB ESCC. Participants receive 1-2 sessions of HDR brachytherapy, delivered through a thin tube inside the esophagus, starting within three weeks after the first cycle of nivolumab. The brachytherapy dose ranges from 5 to 12 Gy, given in 1-2 fractions, targeting the tumor precisely while avoiding damage to normal tissues. Nivolumab is given intravenously every two weeks for several cycles alongside brachytherapy, but chemotherapy is not given on brachytherapy days. Imaging and CT scans are used for treatment planning and applicator adjustment. During the study, participants will have regular follow-up visits with imaging tests and blood samples to monitor treatment response, safety, and tumor markers. Researchers will measure the 12-month locoregional failure rate as the primary outcome and also monitor overall survival, progression-free survival, response rates, disease control, side effects, tube dependence, tumor immune activity, and circulating tumor DNA over up to 24 months. The total participation time may last up to two years with close monitoring for side effects and disease progression.

Brachytherapy With Radiotherapy and Immunotherapy: Guided HDR Trial in Esophageal Squamous Cell Carcinoma