Guided high‑dose‑rate esophageal brachytherapy with radiotherapy and nivolumab for esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single‑arm Phase II trial enrolls patients with locally advanced esophageal squamous cell carcinoma who previously received external beam radiotherapy with platinum‑fluoropyrimidine chemotherapy and have started nivolumab. Participants receive 1–2 fractions of guided HDR esophageal brachytherapy (5–12 Gy per fraction) within three weeks after starting nivolumab and continue on nivolumab with scheduled follow‑up. The primary endpoint is the 12‑month cumulative incidence of locoregional failure, and secondary endpoints include overall survival, progression‑free survival, response rates, safety, tube‑dependence‑free survival, tumor‑infiltrating lymphocytes, and circulating tumor DNA dynamics. Patients are monitored with clinical visits, imaging, and blood tests to document tumor response and treatment safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• National Taiwan University Hospital Yunlin Branch
  Huwei, Yunlin County, Taiwan Recruiting

Study contacts

• Principal investigator: Yen-Ting Liu, MD — National Taiwan University Hospital
• Study coordinator: Yen-Ting Liu, MD
• Email: nickliucool@ntuh.gov.tw
• Phone: +886-2-33663366

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.