NCT06125769Recruiting
LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 30 Oct 2023
- Start date
- 15 Jan 2024
- Primary completion date
- 1 Nov 2028
- Lead sponsor
- Azienda Sanitaria Ospedaliera
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06125769
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 15 Jan 2024 to the primary completion date, 1 Nov 2028
- 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.
Prior treatment
- Prior radiotherapy or chemotherapy
- Prior biliary surgical resection or attempted surgical resection
- Prior neoplasms, except those treated curatively for more than 5 years without recurrence
- Medical-surgical contraindications for liver transplantation
Other illness
- Uncontrollable infection
- Present or past evidence of extrahepatic metastatic disease
- Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study
Other
- Diameter of tumor \>3cm
- Presence of intra-hepatic metastases or iCCA
- Transperitoneal biopsy (including percutaneous ecography-guided FNA)
- Pregnant or breastfeeding women
Who the study is looking for
- 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
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 |
|---|---|---|---|
| Azienda Ospedale Università di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.