Clinical trial · Observational
Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA
NCT06986486CI-TRIAL-00090108pCOLArecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Klatskin Tumor | Hilar Cholangiocarcinoma | ALIAS | 0.90 |
| Perihilar Cholangiocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Transplant
- description
- Patients with liver-limited unresectable perihilar cholangiocarcinoma with no other non-oncological contraindication to liver transplantation
Primary outcomes (1)
- measure
- 3-year overall survival
- timeFrame
- 3 years
- description
- To evaluate overall survival at 36 months in patients with unresectable hilar cholangiocarcinoma treated with neoadjuvant chemotherapy and SBRT followed by liver transplantation according to the modified Mayo Clinic protocol
Secondary outcomes (3)
- measure
- 3-year recurrence-free survival
- timeFrame
- 3 years
- description
- To evaluate recurrence-free survival at 36 months in patients with unresectable hilar cholangiocarcinoma treated with neoadjuvant chemotherapy and SBRT followed by liver transplantation according to the modified Mayo Clinic protocol
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Intrahepatic cholangiocarcinoma * Uncontrolled infection * Concomitant malignancies or history of other malignancies in the previous 5 years
References
Publications (0)
Data not yet available
No reference posted for this study.