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

Recruiting now · Phase 2

Conditions studied: Esophageal Cancer, Esophageal Squamous Cell Carcinoma

In brief

The goal of this clinical trial is to learn if adding high-dose-rate (HDR) brachytherapy can improve outcomes in patients with locally advanced esophageal squamous cell carcinoma (ESCC) who have already received external beam radiotherapy (EBRT), chemotherapy, and the immune therapy drug nivolumab. The main questions it aims to answer are: * Does HDR brachytherapy reduce the chance of the cancer coming back in the esophagus or nearby areas within 12 months? * What side effects or safety issues occur when HDR brachytherapy is given after EBRT, chemotherapy, and nivolumab? Participants will: * Receive 1-2 sessions of HDR brachytherapy delivered through a thin tube placed inside the esophagus, within three weeks after starting nivolumab. * Continue nivolumab and be monitored with regular follow-up visits, imaging tests, and blood samples to check treatment response and safety.

Key facts

Study ID: NCT07152678
Run by: National Taiwan University Hospital
People needed: 60
Starts: 2025-09-01
Expected to finish: 2028-09-01
Last updated by the study team: 2025-09-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age of 18-85 years, with ECOG performance 0-2.
Locally-advanced esophageal squamous cell carcinoma with clinical stage III, IVA with biopsy proven.
Prior treatment with EBRT (40-50.4 Gy in 20-28 fractions) and platinum + fluoropyrimidine chemotherapy, with residual or progressive disease, and deemed inoperable or unable to undergo surgery.
No prior exposure to ICIs and had received first cycle of nivolumab after CCRT.
Biopsy proven with PD-L1 [tumor cell (TC) ≥ 1%]
Required at least one measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Patients with limited stage IVB disease (e.g., non-visceral lymph node metastasis) may be enrolled if the primary tumor is locally dominant and suitable for brachytherapy, based on investigator's discretion.

You may not qualify if…

Current or past history of severe hypersensitivity to any other antibody products.
Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment.
Patients with active, known or suspected autoimmune disease
Stenosis of esophageal lumen that cannot performed brachytherapy
Involvement of tracheal mucosa or bronchial mucosa.
The distribution of the lesions of interest exceeds 10 cm range.
The patient is participating in other interventional clinical trials associated with immunotherapy.
The patient is scheduled to undergo esophagostomy.

Where it is running

National Taiwan University Hospital Yunlin Branch — Huwei, Yunlin County, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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