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

Overview

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.

Interventions

• Procedure Liver transplantation
  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.

Primary outcome measures

• Overall Survival (OS) [Time frame: 3 and 5 years]

Secondary outcome measures (11)

• Overall survival comparison with chemotherapy alone [Time frame: 3 years]
• Progression-Free Survival (PFS) [Time frame: 3 and 5 years]
• Overall survival from the time of recurrence [Time frame: 5 years]
• Progression-free survival comparison with chemotherapy alone [Time frame: 3 years]
• Biological markers [Time frame: 5 years]
• Morbidity [Time frame: 90 days]
• Cancer-related mortality [Time frame: 3 and 5 years]
• Drop out [Time frame: 5 years]
• Concordance of surgical and PET/MRI staging [Time frame: Perioperative]
• Quality of life assessed using EORTC QLQ-C30 [Time frame: 5 years]
• Quality of life assessed using FACT-Hep questionnaire [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 1 center

• Azienda Ospedale Università di Padova — Padova

Identifiers

NCT: NCT06125769 · AOP 3007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗