NCT06125769 LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
| NCT ID | NCT06125769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Sanitaria Ospedaliera |
| Condition | Perihilar Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-01-15 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Enrico Gringeri, Prof.
PRINCIPAL INVESTIGATOR
Azienda Ospedale Università di Padova
Frequently Asked Questions
Who can join the NCT06125769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Perihilar Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06125769 currently recruiting?
Yes, NCT06125769 is actively recruiting participants. Contact the research team at enrico.gringeri@unipd.it for enrollment information.
Where is the NCT06125769 trial being conducted?
This trial is being conducted at Padova, Italy.
Who is sponsoring the NCT06125769 clinical trial?
NCT06125769 is sponsored by Azienda Sanitaria Ospedaliera. The principal investigator is Enrico Gringeri, Prof. at Azienda Ospedale Università di Padova. The trial plans to enroll 50 participants.