Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06098547

LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)

Led by Azienda Sanitaria Ospedaliera · Updated on 2024-01-24

10

Participants Needed

1

Research Sites

511 weeks

Total Duration

On this page

Sponsors

A

Azienda Sanitaria Ospedaliera

Lead Sponsor

I

Istituto Oncologico Veneto IRCCS

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of intrahepatic cholangiocarcinoma (iCCA)
  • First diagnosis of iCCA
  • Recurrence after complete hepatic resection without lymph node or distant metastasis and no major vessel invasion
  • Disease not suitable for liver surgery due to tumor location, extent, or liver dysfunction
  • No major vascular invasion, extrahepatic disease, or regional lymph node involvement on imaging
  • No evidence of metastatic disease outside the liver after chest-abdomen-pelvis CT and PET-MR or PET-CT
  • At least six months since first diagnosis or recurrence before joining the transplant waiting list
  • At least six months of standard chemotherapy with disease stability or partial response at listing
  • Blood counts and liver/kidney function within specified safe limits
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Body mass index (BMI) between 18 and 30 kg/m2
  • Signed informed consent and willingness to cooperate with treatment and follow-up
Not Eligible

You will not qualify if you...

  • Tumor invading nearby extrahepatic structures or major hepatic vessels by direct invasion
  • Tumor penetrating the visceral peritoneum
  • Previous history of extrahepatic metastatic disease
  • Prior cancers except those cured more than 5 years ago without recurrence
  • Known HIV infection
  • Previous solid organ or bone marrow transplantation
  • Substance abuse or medical, psychological, or social conditions interfering with study participation
  • Pregnant or breastfeeding women
  • Medical or surgical reasons preventing liver transplantation
  • Any other reason judged by the investigator to exclude patient from the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Azienda Ospedale Università di Padova

Padova, Italy, 35128

Actively Recruiting

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Research Team

E

Enrico Gringeri, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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