Status:
RECRUITING
Brachytherapy With Radiotherapy and Immunotherapy: Guided HDR Trial in Esophageal Squamous Cell Carcinoma
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Esophageal Cancer
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 alrea...
Detailed Description
This is a single-arm, phase II clinical trial designed to evaluate the efficacy and safety of high-dose-rate (HDR) esophageal brachytherapy in combination with external beam radiotherapy (EBRT), chemo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07152678
Start Date
September 1 2025
End Date
September 1 2028
Last Update
September 3 2025
Active Locations (1)
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1
National Taiwan University Hospital Yunlin Branch
Huwei, Yunlin County, Taiwan, 632