Clinical trial NCT06125769: LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
Official title: LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perihilar Cholangiocarcinoma
Keywords: Liver transplantation
Lead sponsor: Azienda Sanitaria Ospedaliera
Sponsor class: OTHER
Collaborators: name: Istituto Oncologico Veneto IRCCS
First posted: 2023-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 3 and 5 years
Secondary outcomes:
measure: Overall survival comparison with chemotherapy alone
timeFrame: 3 years
measure: Progression-Free Survival (PFS)
timeFrame: 3 and 5 years
measure: Overall survival from the time of recurrence
timeFrame: 5 years
measure: Progression-free survival comparison with chemotherapy alone
timeFrame: 3 years
measure: Biological markers
timeFrame: 5 years
measure: Morbidity
timeFrame: 90 days
measure: Cancer-related mortality
timeFrame: 3 and 5 years
measure: Drop out
timeFrame: 5 years
measure: Concordance of surgical and PET/MRI staging
timeFrame: Perioperative
measure: Quality of life assessed using EORTC QLQ-C30
timeFrame: 5 years
measure: Quality of life assessed using FACT-Hep questionnaire
timeFrame: 5 years
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedale Università di Padova
Study officials:
affiliation: Azienda Ospedale Università di Padova
name: Enrico Gringeri, Prof.
role: PRINCIPAL_INVESTIGATOR
References: