Liver transplantation for patients with advanced intrahepatic cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

LIRICA is a prospective non-randomized study that investigates the outcomes of liver transplantation in patients with unresectable intrahepatic cholangiocarcinoma (iCCA) following a downstaging protocol using standard chemotherapy. The study aims to assess overall survival and quality of life post-transplant while identifying biological markers and clinical factors that predict better outcomes. Additionally, it explores the utility of preoperative PET-MR imaging in evaluating lymph node involvement and correlating these findings with histological results after lymphadenectomy.

Why it matters

Who can join: the full rules

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

Where it's running

• Azienda Ospedale Università di Padova
  Padova, Italy Recruiting

Study contacts

• Principal investigator: Enrico Gringeri, Prof. — Azienda Ospedale Università di Padova
• Study coordinator: Enrico Gringeri, Prof.
• Email: enrico.gringeri@unipd.it
• Phone: +39 0498218547

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.