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NCT Number: NCT06125769

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

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.

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Key information

Conditions

Perihilar Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedale Università di Padova

Padova, PADOVA, 35128, Italy

Location status: Recruiting

Location contact

Alessandra Bertacco, Dr.

SUB_INVESTIGATOR

Alessandro Furlanetto, Dr.

SUB_INVESTIGATOR

Alessandro Vitale, Prof.

SUB_INVESTIGATOR

Annalisa Dolcet, Dr.

SUB_INVESTIGATOR

Caterina Solda', Dr.

SUB_INVESTIGATOR

Domenico Bassi, Dr.

SUB_INVESTIGATOR

Enrico Gringeri, Prof.

CONTACT

[email protected]

+39 0498218547

Enrico Gringeri, Prof.

PRINCIPAL_INVESTIGATOR

Francesca Bergamo, Dr.

SUB_INVESTIGATOR

Francesco Enrico D'Amico, Prof

SUB_INVESTIGATOR

Francesco Ferrara, Dr.

SUB_INVESTIGATOR

Jacopo Lanari, Dr.

SUB_INVESTIGATOR

Marco Krengli, Prof.

SUB_INVESTIGATOR

Mario Domenico Rizzato, Dr.

SUB_INVESTIGATOR

Martina Gambato, Dr.

SUB_INVESTIGATOR

Riccardo Boetto, Dr.

SUB_INVESTIGATOR

Sara Galuppo, Dr.

SUB_INVESTIGATOR

Sara Lonardi, Dr.

SUB_INVESTIGATOR

Umberto Cillo, Prof.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 3 and 5 years

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

Secondary outcomes

  1. Overall survival comparison with chemotherapy alone

    Time frame: 3 years

    Comparison of 3-year survival between patients enrolled in the LITALHICA study and survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV)

  2. Progression-Free Survival (PFS)

    Time frame: 3 and 5 years

    Survival from time of transplantation to time of death or first evidence of progression of disease

  3. Overall survival from the time of recurrence

    Time frame: 5 years

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

  4. Progression-free survival comparison with chemotherapy alone

    Time frame: 3 years

    Comparison of 3-year progression-free survival between patients enrolled in the LITALHICA study and progression-free survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV)

  5. Biological markers

    Time frame: 5 years

    Correlation of overall survival and recurrence with tissue and circulating biological markers (immunohistochemistry, proteomics, circulating tumor cells, circulating tumor DNA, new molecular markers)

  6. Morbidity

    Time frame: 90 days

    Morbidity at 90 days (according to Clavien-Dindo and Comprehensive Complication Index, CCI)

  7. Cancer-related mortality

    Time frame: 3 and 5 years

    Risk of mortality with sole relation to death by tumor progression

  8. Drop out

    Time frame: 5 years

    Percentage of patients who do not complete the procedure (drop-out) stratified by cause

  9. Concordance of surgical and PET/MRI staging

    Time frame: Perioperative

    Asses if lymph nodes described as suspicious at the preoperative PET-MRI confirm to be pathological at the histological evaluation after lymphadenectomy of the hepatic hilum and exploratory laparotomy

  10. Quality of life assessed using EORTC QLQ-C30

    Time frame: 5 years

    Quality of life assessed using EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer QLQ Core Questionnaire) 30 items questionnaire (scale 1-4 or 1-7, 1 being the lowest and 4 or 7 the highest, accordingly)

  11. Quality of life assessed using FACT-Hep questionnaire

    Time frame: 5 years

    Quality of life assessed using FACT-Hep questionnaire (Functional Assessment of Cancer Therapy - Hepatobiliary) questionnaire about quality of life in the last 7 days (scale 0-4, 0 being the lowest and 4 the highest)

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Gringeri, Prof.

CONTACT

[email protected]

+39 0498218547

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Ospedaliera

Other

Collaborators

  • Istituto Oncologico Veneto IRCCS

Registry information

Acronym: LITALHICA

Important dates

Study start
2024
Primary completion
2028
Study completion
2033
First posted
Nov 9, 2023
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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