NCT07235007 Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma
| NCT ID | NCT07235007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aichi Medical University |
| Condition | Extrahepatic Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2027-12-31 |
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.
This trial targets 120 participants in total. It began in 2025-11-20 with a primary completion date of 2027-12-31.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed extrahepatic cholangiocarcinoma (eCCA). Unresectable disease (unresectable due to tumor/patient factors, or patient refusal of surgery). Biliary obstruction requiring drainage, demonstrated by abnormal cholestatic liver tests, elevated bilirubin, radiologic evidence, or existing biliary drainage. Planned initiation of first-line systemic therapy with durvalumab + gemcitabine + cisplatin (GCD). Age ≥18 years. Able to provide written informed consent. Exclusion Criteria: Prior radiotherapy or systemic therapy for the current eCCA. Presence of a self-expanding metal stent that cannot be endoscopically removed. Surgically altered anatomy except for Billroth-I; prior biliary reconstruction. History of chronic cholangitis (e.g., primary sclerosing cholangitis, IgG4-related cholangitis). Expected survival \<3 months. Inability to insert an oral endoscope or reach the papilla. Contraindication to endobiliary RFA. Pregnancy or possible pregnancy. Any condition judged unsuitable by the investigator.
Contact & Investigator
Tadahisa Inoue, Associate Professor
PRINCIPAL INVESTIGATOR
Department of Gastroenterology, Aichi Medical University
Frequently Asked Questions
Who can join the NCT07235007 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Extrahepatic Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07235007 currently recruiting?
Yes, NCT07235007 is actively recruiting participants. Contact the research team at tinoue-tag@umin.ac.jp for enrollment information.
Where is the NCT07235007 trial being conducted?
This trial is being conducted at Aichi, Japan, Aichi, Japan, Aichi, Japan, Gifu, Japan and 4 additional locations.
Who is sponsoring the NCT07235007 clinical trial?
NCT07235007 is sponsored by Aichi Medical University. The principal investigator is Tadahisa Inoue, Associate Professor at Department of Gastroenterology, Aichi Medical University. The trial plans to enroll 120 participants.