Clinical trial NCT06098547: LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)
Official title: LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: Liver transplantation
Lead sponsor: Azienda Sanitaria Ospedaliera
Sponsor class: OTHER
Collaborators: name: Istituto Oncologico Veneto IRCCS
First posted: 2023-10-24
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: 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.


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

Primary outcomes:
measure: Overall Survival
timeFrame: 3 and 5 years
Secondary outcomes:
measure: OS comparison with chemotherapy alone
timeFrame: 3 years
measure: Disease-Free Survival (DFS)
timeFrame: 3 and 5 years
measure: Overall survival from the time of recurrence
timeFrame: 5 years
measure: PFS 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_RM staging (number, size, location)
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: