LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)

Recruiting now · Not applicable

Conditions studied: Intrahepatic Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT06098547

Run by

Azienda Sanitaria Ospedaliera

People needed

10

Starts

2024-01-15

Expected to finish

2033-11-01

Last updated by the study team

2024-01-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Azienda Ospedale Università di Padova — Padova, Italy (enrolling)

Full record on ClinicalTrials.gov

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