Trial Title:
LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)
NCT ID:
NCT06098547
Condition:
Intrahepatic Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
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:
LIRICA is a prospective non-randomized study aimed at exploring the outcome of liver
transplantation in selected patients with unresectable iCCA after a downstaging/disease
control protocol 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-MR,
especially in relation to lymph node locations, by correlating the results with
histological examination after iliac lymphadenectomy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed diagnosis of iCCA
- First diagnosis of iCCA
- Recurrence after R0 hepatic resection, N0, M0 without macrovascular invasion
- 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)
- At least six months have passed since the first diagnosis of iCCA (or recurrence) to
the date of inclusion on the liver transplant waiting list
- The patient has received at least six months of SOC chemotherapy, achieving disease
stability or partial response (according to RECIST version 1.1) at the time of
listing for transplantation
- Hematochemical evaluation: Hb ≥ 9 g/dL, Leukocytes ≥ 3.0 X 109/L, Neutrophils ≥ 1.5
X 109/L, Platelets ≥ 100,000/mm3 (≥ 10 X 109/L), Total Bilirubin ≤ 3 mg/dL (≤ 51
umol/L), AST or ALT ≤ 5 times the upper limit of normal, Serum Creatinine and Urea <
1.5 times the upper limit of normal
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1
- Patient's BMI ≥ 18 and ≤ 30 kg/m2
- 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:
- Tumor involving nearby extrahepatic structures (including involvement of major
hepatic vessels) by direct invasion (T4 per AJCC 8th edition)
- Tumor penetrating the visceral peritoneum (T3 per AJCC 8th edition)
- Previous extrahepatic metastatic disease
- Prior neoplasms, except those treated curatively for more than 5 years without
recurrence
- Known history of human immunodeficiency virus (HIV) infection
- Known history of solid organ or bone marrow transplantation
- 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:
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:
Jacopo Lanari, 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 D Rizzato, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Martina Gambato, 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/NCT06098547
