Liver transplantation for patients with advanced intrahepatic cholangiocarcinoma
LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)
This study is testing whether liver transplantation can help people with advanced bile duct cancer who can't have surgery feel better and live longer after receiving chemotherapy first.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Azienda Sanitaria Ospedaliera Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Padova) |
| Trial ID | NCT06098547 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed iCCA who are not suitable for surgical resection and have achieved disease stability after chemotherapy.
Not a fit: Patients with extrahepatic metastatic disease or major vascular invasion will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced iCCA, potentially improving survival rates and quality of life.
How similar studies have performed: While liver transplantation for iCCA is a novel approach, similar studies have shown promising results in other liver cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Padova
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.