Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Perihilar Cholangiocarcinoma, Klatskin Tumor. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA
Overview
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).
Detailed description
Patients with unresectable pCCA who fit within inclusion criteria will be enrolled in the study. They will undergo staging laparoscopy with nodal sampling at the hepatic hilum. In case of negative staging (no peritoneal carcinomatosis, no positive hilar lymph nodes, negative peritoneal washing), they will receive downstaging with gemcitabine-cisplatin +/- durvalumab for 2 cycles, followed by SBRT, followed by at least 4 other cycles of gemcitabine-cisplatin +/- durvalumab. After downstaging, they will undergo disease restaging and, if at least disease stability is confirmed, they will undergo transplant screening and listing. Treatment with gemcitabine-cisplatin + durvalumab will continue until liver transplant, progression or unacceptable toxicity.
During listing, restaging will be performed every two months with CT scan and/or MRI, molecular markers and FDG-PET. The target interval between listing and transplant should be less than 90 days.
Primary outcome measures
- 3-year overall survival [Time frame: 3 years]
Secondary outcome measures (3)
- 3-year recurrence-free survival [Time frame: 3 years]
- Safety and feasibility [Time frame: 3 years]
- Quality of life [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Istituto Nazionale Tumori di Milano — Milan
Identifiers
NCT: NCT06986486 · 254-24