NCT06098547 LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)
| NCT ID | NCT06098547 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Sanitaria Ospedaliera |
| Condition | Intrahepatic Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-01-15 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Enrico Gringeri, Prof.
PRINCIPAL INVESTIGATOR
Azienda Ospedale Università di Padova
Frequently Asked Questions
Who can join the NCT06098547 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Intrahepatic Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06098547 currently recruiting?
Yes, NCT06098547 is actively recruiting participants. Contact the research team at enrico.gringeri@unipd.it for enrollment information.
Where is the NCT06098547 trial being conducted?
This trial is being conducted at Padova, Italy.
Who is sponsoring the NCT06098547 clinical trial?
NCT06098547 is sponsored by Azienda Sanitaria Ospedaliera. The principal investigator is Enrico Gringeri, Prof. at Azienda Ospedale Università di Padova. The trial plans to enroll 10 participants.