Status:
RECRUITING
LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)
Lead Sponsor:
Azienda Sanitaria Ospedaliera
Collaborating Sponsors:
Istituto Oncologico Veneto IRCCS
Conditions:
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
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 stand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2033
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06098547
Start Date
January 15 2024
End Date
November 1 2033
Last Update
January 24 2024
Active Locations (1)
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1
Azienda Ospedale Università di Padova
Padua, Italy, 35128