Endoscopic intraductal radiofrequency ablation plus radiotherapy for extrahepatic cholangiocarcinoma
Official title: Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma: A Prospective, Single-arm, Multicenter Study
Run by National Cancer Center, Korea · NCT06168292 · Data updated 2026-11-12
This treatment tests whether combining endoscopic intraductal radiofrequency ablation with radiotherapy can better control locoregional extrahepatic cholangiocarcinoma in adults who cannot have surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 53 (estimated) |
| Sponsor | National Cancer Center, Korea Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Goyang-si, Other) |
| Status | Recruiting |
| Started | April 1, 2024 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2030 |
| Registry record updated | June 19, 2025 |
| Trial ID | NCT06168292 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥20 years) with cytopathologically confirmed, inoperable locoregional extrahepatic cholangiocarcinoma who need biliary drainage and have no distant metastases are ideal candidates.
✕Probably not a fit
Patients with metastatic (stage IV) disease, malignant ascites, intrahepatic cholangiocarcinoma, life expectancy under three months, or contraindications to endoscopy or ID-RFA are unlikely to benefit from this local combined approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with cytologically confirmed, inoperable extrahepatic cholangiocarcinoma who require biliary drainage are enrolled and undergo ERCP with tissue sampling and assessment of tumor extent. During the initial biliary drainage procedure, intraductal radiofrequency ablation (ID-RFA) is performed and a biliary stent is placed, followed by radiotherapy within one month; systemic chemotherapy may be given afterward at the investigator's discretion. Tumor response and stent function are monitored with CT or MRI every two months using RECIST 1.1 criteria. Patients with distant metastases, malignant ascites, intrahepatic cholangiocarcinoma, very short life expectancy, or contraindications to endoscopy/ID-RFA are excluded.
Why it matters
Potential benefit: If successful, the combined local treatment could improve local tumor control, relieve biliary obstruction, and potentially extend time without progression or the need for more intensive systemic therapy.
How similar studies have gone: Small studies and case series have reported that ID-RFA can improve biliary patency and symptom control, but combining ID-RFA with radiotherapy is relatively novel and lacks large randomized evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients 20 years of age or older, who voluntarily agree to participate in the study and sign the informed consent. 2. Patients with cytopathologically diagnosed inoperable extrahepatic cholangiocarcinoma Exclusion Criteria: 1. Patients who refuse to sign the informed consent 2. Patients with metastatic cancer (stage IV) or malignant ascites 3. Patients with intrahepatic cholangiocarcinoma 4. Patients who are unable to undergo endoscopic procedures as determined by the investigator. 5. Patients with a life expectancy of 3 months or less 6. Patients with ID-RFA contraindications: pacemaker, pregnancy, uncorrected bleeding tendency (PT INR \> 1.5, platelets \< 50,000/mm3)
Where it's running
-
National Cancer Center, Korea
Goyang-si, Other, South Korea Recruiting
Study contacts
- Principal investigator: Sang Myung Woo, M.D — National Cancer Center
- Study coordinator: Sang Myung Woo, M.D
- Email: wsm@ncc.re.kr
- Phone: 82-31-920-1733
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.