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New treatment option for Extrahepatic Cholangiocarcinoma
Official title Repeated Endobiliary Radiofrequency Ablation Plus Durvalumab, Gemcitabine, and Cisplatin for Unresectable Extrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT07235007
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Planned initiation of first-line systemic therapy with durvalumab + gemcitabine + cisplatin (GCD).
- Age ≥18 years.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aichi, Japan
- Gifu, Japan
- Busan, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aichi, Japan; Gifu, Japan; Busan, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.