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New treatment option for Intrahepatic Cholangiocarcinoma
Official title LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)
ClinicalTrials.gov ID: NCT06098547
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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
You likely can't join 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Padova, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Padova, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.