NCT07152678 Brachytherapy With Radiotherapy and Immunotherapy: Guided HDR Trial in Esophageal Squamous Cell Carcinoma
| NCT ID | NCT07152678 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Taiwan University Hospital |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-09 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Yen-Ting Liu, MD
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT07152678 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07152678 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07152678 currently recruiting?
Yes, NCT07152678 is actively recruiting participants. Contact the research team at nickliucool@ntuh.gov.tw for enrollment information.
Where is the NCT07152678 trial being conducted?
This trial is being conducted at Huwei, Taiwan.
Who is sponsoring the NCT07152678 clinical trial?
NCT07152678 is sponsored by National Taiwan University Hospital. The principal investigator is Yen-Ting Liu, MD at National Taiwan University Hospital. The trial plans to enroll 60 participants.
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