RecruitingNot ApplicableNCT06098547

LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)


Sponsor

Azienda Sanitaria Ospedaliera

Enrollment

10 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study — called LIRICA — is testing whether liver transplantation can be a life-saving option for certain patients with intrahepatic cholangiocarcinoma (a cancer that starts inside the liver's bile ducts) that cannot be removed with surgery and has responded well to chemotherapy. **You may be eligible if...** - You have a confirmed diagnosis of intrahepatic cholangiocarcinoma (bile duct cancer within the liver) - This is your first diagnosis, or the cancer came back after a successful prior surgery but has not spread outside the liver - Your cancer cannot be removed by surgery due to its location, size, or liver condition - There are no signs of cancer outside the liver (no distant metastases or major blood vessel involvement) - You have received at least 6 months of standard chemotherapy and the cancer is stable or shrinking - Your general health and body weight (BMI 18–30) are acceptable for transplantation - At least 6 months have passed since diagnosis before being considered for transplant listing **You may NOT be eligible if...** - The cancer has spread outside the liver or involves nearby structures - You have not responded to chemotherapy (cancer is growing) - You have significant other medical conditions that would make transplant unsafe - Your BMI is outside the acceptable range Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELiver transplantation

Patients will undergo liver transplantation according to the standard procedures of the institutional Center's protocol (cadaveric or living donor transplantation, whole or partial liver). Liver transplantation is preceded by an exploratory laparotomy with clinical evaluation and frozen section examination of lymph nodes in the hepatoduodenal ligament and along the common hepatic artery/celiac axis.


Locations(1)

Azienda Ospedale Università di Padova

Padova, Italy

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NCT06098547


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