LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
Italy50 participantsStarted 2024-01-15
Plain-language summary
LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment with standard of care chemotherapy, in terms of overall survival and quality of life. Additionally, the study aims to identify pre-transplant biological markers and clinical factors that can stratify patients with the best post-transplant prognosis. Finally, the study aims to investigate the role of preoperative PET-MRI, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of pCCA (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, or biliary ploidy with a malignant appearing stricture on cholangiography)
* Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC
* Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes
* No extrahepatic metastatic disease
* Radial tumor diameter ≤3 cm
* At least six months between first diagnosis of pCCA and date of inclusion
* At least six months of SOC chemotherapy, achieving disease stability or partial response
Exclusion Criteria:
* Uncontrollable infection
* Prior radiotherapy or chemotherapy
* Prior biliary surgical resection or attempted surgical resection
* Diameter of tumor \>3cm
* Presence of intra-hepatic metastases or iCCA
* Present or past evidence of extrahepatic metastatic disease
* Transperitoneal biopsy (including percutaneous ecography-guided FNA)
* Prior neoplasms, except those treated curatively for more than 5 years without recurrence
* Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study
* Pregnant or breastfeeding women
* Medical-surgical contraindications for liver transplantation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.