LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)

NCT ID: NCT06098547

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2033-11-01

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.

Conditions

Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study population

Candidates will be evaluated by theMultidisciplinary Group after routine radiological studies (CT, MRI, PET-MR/CT).

Patients will receive 6 months of standard of care chemotherapy and undergo PET-MR with FDG to exclude the presence of extrahepatic disease.

Following completion of therapy, patients will undergo radiological restaging. If the disease is resectable, the patient will be considered for curative-intent surgical resection; if not, the patients will be evaluated by the Center's Multidisciplinary Transplantation Group.

Patients will continue chemotherapy until a compatible liver becomes available. If there are no further contraindications, exploratory laparotomy and surgical nodal staging of the tumor will be performed at the time of transplantation. If there are no signs of extrahepatic disease, transplantation will be conducted according to institutional protocols.

Group Type: EXPERIMENTAL

Liver transplantation

Intervention Type: 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.

Interventions

Liver transplantation

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role: collaborator

Azienda Sanitaria Ospedaliera

OTHER

Sponsor Role: lead

Responsible Party

Enrico Gringeri

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrico Gringeri, Prof.

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedale Università di Padova

Locations

Azienda Ospedale Università di Padova

Padua, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Enrico Gringeri, Prof.

Role: CONTACT

enrico.gringeri@unipd.it

+39 0498218547

Facility Contacts

Enrico Gringeri, Prof.

Role: primary

enrico.gringeri@unipd.it

+39 0498218547

Other Identifiers

LIRICA

Identifier Type: OTHER

Identifier Source: secondary_id

AOP 3006

Identifier Type: -

Identifier Source: org_study_id