NCT06986486Recruiting
Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA
Source: ClinicalTrials.gov · Last updated 23 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cholangiocarcinoma using chemotherapy +/- immunotherapy and stereotactic body radiation therapy (SBRT).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 8 (estimated)
- First submitted
- 15 May 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jan 2030
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06986486
What you commit to
- Study type: Observational
- Planned participants: 8
- From 1 Jun 2025 to the primary completion date, 1 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled infection
- Concomitant malignancies or history of other malignancies in the previous 5 years
Other
- Intrahepatic cholangiocarcinoma
Who the study is looking for
- Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by:
- Transcatheter biopsy or brush cytology
- CA-19.9 \> 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography
- Biliary ploidy by FISH with a malignant appearing stricture on cholangiography
- Age between 18 years and 70 years
- Absence of intra- and extrahepatic metastases
- Absence of lymph-nodal metastases at any site
- Biliary stenting of all liver districts
- No contraindications to liver transplantation
- No concomitant malignancies or history of other malignancies in the previous 5 years
- Written informed consent
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale Tumori di Milano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.