Actively Recruiting
Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma
Led by Aichi Medical University · Updated on 2026-01-13
120
Participants Needed
8
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This international, multicenter, open-label randomized controlled trial evaluates whether repeated endobiliary radiofrequency ablation (EB-RFA) improves overall survival in patients with unresectable extrahepatic cholangiocarcinoma undergoing first-line systemic therapy with durvalumab plus gemcitabine and cisplatin (GCD). Eligible patients will be randomized 1:1 to EB-RFA with plastic stent placement or standard plastic stenting alone. A scheduled second endoscopic session will be performed at 3 months in both groups (repeat EB-RFA only in the EB-RFA arm). The primary endpoint is overall survival. Secondary endpoints include time to recurrent biliary obstruction, progression-free survival, adverse events, and technical/clinical success.
CONDITIONS
Official Title
Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed extrahepatic cholangiocarcinoma (eCCA)
- Unresectable disease due to tumor or patient factors, or patient refusal of surgery
- Biliary obstruction requiring drainage shown by abnormal liver tests, elevated bilirubin, imaging, or existing drainage
- Planned first-line systemic therapy with durvalumab, gemcitabine, and cisplatin (GCD)
- Age 18 years or older
- Able to provide written informed consent
You will not qualify if you...
- Prior radiotherapy or systemic therapy for the current extrahepatic cholangiocarcinoma
- Presence of a self-expanding metal stent that cannot be endoscopically removed
- Surgically altered anatomy except for Billroth-I; previous biliary reconstruction
- History of chronic cholangitis such as primary sclerosing cholangitis or IgG4-related cholangitis
- Expected survival less than 3 months
- Inability to insert an oral endoscope or reach the bile duct opening
- Contraindication to endobiliary radiofrequency ablation
- Pregnancy or possible pregnancy
- Any condition judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Aichi Medical University
Aichi, Japan
Actively Recruiting
2
Nagoya City University Hospital
Aichi, Japan
Actively Recruiting
3
Nagoya City University Midori Municipal Hospital
Aichi, Japan
Actively Recruiting
4
Gifu University Hospital
Gifu, Japan
Actively Recruiting
5
Pusan National University Hospital
Busan, South Korea
Actively Recruiting
6
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
Actively Recruiting
7
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, South Korea
Actively Recruiting
8
Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
Actively Recruiting
Research Team
T
Tadahisa Inoue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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