LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)

NCT06125769 | Recruiting

• 1 other identifier: AOP 3007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Perihilar Cholangiocarcinoma

Keywords

Liver transplantation

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Survival from time of transplantation to time of death or last follow up

  3 and 5 years

Secondary Outcomes (11)

• Overall survival comparison with chemotherapy alone

  3 years

• Progression-Free Survival (PFS)

  3 and 5 years

• Overall survival from the time of recurrence

  5 years

• Progression-free survival comparison with chemotherapy alone

  3 years

• Biological markers

  5 years

Study Arms (1)

Study population

EXPERIMENTAL

Candidates will be evaluated by a National Multidisciplinary Group after routine radiological studies (CT, MRI, PET-MRI/CT). Patients will receive 6 months of standard of care chemotherapy and undergo PET-MRI with FDG to exclude the presence of extrahepatic disease. Following completion of therapy, patients will undergo radiological restaging: those who demonstrate stable disease at this stage are considered eligible for definitive listing for LT. Patients will continue chemotherapy until a compatible liver becomes available. If there are no further contraindications, exploratory laparotomy and surgical nodal staging of the tumor will be performed at the time of transplantation. If there are no signs of extrahepatic disease, transplantation will be conducted according to institutional protocols.

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

Patients will undergo liver transplantation according to the standard procedures of the institutional Center's protocol (cadaveric or living donor transplantation, whole or partial liver). Liver transplantation is preceded by an exploratory laparotomy with clinical evaluation and frozen section examination of lymph nodes in the hepatoduodenal ligament and along the common hepatic artery/celiac axis.

Study population

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 of SOC chemotherapy, achieving disease stability or partial response

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Ospedaliera: lead
• Istituto Oncologico Veneto IRCCS: collaborator

Study Sites (1)

Azienda Ospedale Università di Padova

Padua, PADOVA, 35128, Italy

RECRUITING

MeSH Terms

Conditions

Klatskin Tumor

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Enrico Gringeri, Prof.

  Azienda Ospedale Università di Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Gringeri, Prof.

CONTACT

+39 0498218547; enrico.gringeri@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 9, 2023
• Study Start: January 15, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2033
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)