Trial Title:
LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
NCT ID:
NCT06125769
Condition:
Perihilar Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Klatskin Tumor
Conditions: Keywords:
Liver transplantation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Liver transplantation
Description:
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.
Arm group label:
Study population
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.
Criteria for 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)
- Disease considered unsuitable for hepatic resection based on tumor location and
extent or underlying liver dysfunction
- Absence of major vascular invasion, extrahepatic disease, or involvement of regional
lymph nodes detected on radiological study
- No evidence of extrahepatic metastatic disease after chest-abdomen-pelvis CT and
PET-MR (or PET-CT)
- Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic
involvement of CBD) or resectable pCCA arising in PSC
- Radial tumor diameter <3 cm
- At least six months have passed since the first diagnosis of pCCA to the date of
inclusion on the liver transplant waiting list
- The patient has received at least six months of standard of care (SOC) chemotherapy,
achieving disease stability or partial response (according to RECIST criteria
version 1.1) at the time of listing for transplantation
- Absence of medical or surgical contraindication to liver transplantation
- Signed informed consent, and expected patient cooperation for treatment and
follow-up, must be obtained and documented according to good clinical practice and
national/local regulations
Exclusion Criteria:
- Diagnosis of intrahepatic cholangiocarcinoma (iCCA)
- Uncontrollable infection
- Prior radiotherapy or chemotherapy
- Prior biliary surgical resection or attempted surgical resection
- Diameter of tumor >3cm
- Presence of intra-hepatic metastases
- 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 or with the evaluation of study
outcomes
- Pregnant or breastfeeding women
- Medical-surgical contraindications for liver transplantation
- Any reason for which, in the investigator's judgment, the patient should not
participate in the study
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Azienda Ospedale Università di Padova
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Enrico Gringeri, Prof.
Phone:
+39 0498218547
Email:
enrico.gringeri@unipd.it
Investigator:
Last name:
Enrico Gringeri, Prof.
Email:
Principal Investigator
Investigator:
Last name:
Umberto Cillo, Prof.
Email:
Sub-Investigator
Investigator:
Last name:
Jacopo Lanari, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Domenico Bassi, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Alessandra Bertacco, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Riccardo Boetto, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Francesco Enrico D'Amico, Prof
Email:
Sub-Investigator
Investigator:
Last name:
Annalisa Dolcet, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Alessandro Vitale, Prof.
Email:
Sub-Investigator
Investigator:
Last name:
Alessandro Furlanetto, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Sara Lonardi, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Francesca Bergamo, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Caterina Solda', Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Mario Domenico Rizzato, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Martina Gambato, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Francesco Ferrara, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Marco Krengli, Prof.
Email:
Sub-Investigator
Investigator:
Last name:
Sara Galuppo, Dr.
Email:
Sub-Investigator
Start date:
January 15, 2024
Completion date:
November 1, 2033
Lead sponsor:
Agency:
Azienda Sanitaria Ospedaliera
Agency class:
Other
Collaborator:
Agency:
Istituto Oncologico Veneto IRCCS
Agency class:
Other
Source:
Azienda Sanitaria Ospedaliera
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06125769
