NCT07152678RecruitingPhase 2

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

A Phase II Study of High-Dose-Rate Esophageal Brachytherapy After External Beam Radiotherapy and Nivolumab in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 60 (estimated)
First submitted: 26 Aug 2025
Start date: Sept 2025
Primary completion date: Sept 2027
Lead sponsor: National Taiwan University Hospital
Diseases: Gastric and esophageal cancer
NCT number: NCT07152678

What you commit to

Study type: Interventional · Phase 2
Planned participants: 60
From Sept 2025 to the primary completion date, Sept 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

The patient is participating in other interventional clinical trials associated with immunotherapy.

Other illness

Current or past history of severe hypersensitivity to any other antibody products.
Patients with active, known or suspected autoimmune disease

Other

Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment.
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 scheduled to undergo esophagostomy.

Who the study is looking for

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.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Taiwan University Hospital Yunlin Branch Coordinator of this site? Confirm its status	Huwei	Taiwan	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.