AzTrials
AzTrials

Intrahepatic CholangiocarcinomaLIRICANCT06098547

LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)

A study testing Liver transplantation in people with Intrahepatic Cholangiocarcinoma, run by Azienda Sanitaria Ospedaliera at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Intrahepatic Cholangiocarcinoma
What is being tested?
Liver transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteItaly
Study dates
15 Jan 2024to 1 Nov 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Enrico Gringeri, Prof. contact

+39 0498218547

enrico.gringeri@unipd.it

Italy1 site, 1 recruiting

  • Azienda Ospedale Università di Padova

    Padova, 35128

    Enrico Gringeri, Prof., +39 0498218547, enrico.gringeri@unipd.it

    Enrico Gringeri, Prof.

    Recruiting

Other trials in Italy

About this study

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.

Being tested
Liver transplantation
Keywords
Liver transplantation
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liver transplantationProcedure or surgery

    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.

Study groups in NCT06098547
Study groupRoleWhat they receive
Study populationExperimentalCandidates will be evaluated by theMultidisciplinary Group after routine radiological studies (CT, MRI, PET-MR/CT). Patients will receive 6 months of standard of care chemotherapy and undergo PET-MR with FDG to exclude the presence of extrahepatic disease. Following completion of therapy, patients will undergo radiological restaging. If the disease is resectable, the patient will be considered for curative-intent surgical resection; if not, the patients will be evaluated by the Center's Multidisciplinary Transplantation Group. Patients will continue chemotherapy until a compatible liver becomes available. If there are no further contraindications, exploratory laparotomy and surgical nodal staging of the tumor will be performed at the time of transplantation. If there are no signs of extrahepatic disease, transplantation will be conducted according to institutional protocols.
Receives: Procedure: Liver transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Survival from time of transplantation to time of death or last follow up

    Measured: 3 and 5 years

Secondary outcomes (11)

  1. OS comparison with chemotherapy alone

    Comparison of 3-year survival between patients enrolled in the LIRICA study and survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV)

    Measured: 3 years

  2. Disease-Free Survival (DFS)

    Survival from time of transplantation to time of death or first evidence of recurrence fo disease

    Measured: 3 and 5 years

  3. Overall survival from the time of recurrence

    Survival from time of recurrence to time of death or last follow up

    Measured: 5 years

  4. PFS comparison with chemotherapy alone

    Comparison of 3-year Progression-Free Survival (PFS) between the per-protocol population of patients enrolled in the LIRICA study and the PFS of the population from the Veneto Oncological Institute (IOV) database

    Measured: 3 years

  5. Biological markers

    Correlation of overall survival and recurrence with tissue and circulating biological markers (immunohistochemistry, proteomics, circulating tumor cells, circulating tumor DNA, new molecular markers)

    Measured: 5 years

  6. Morbidity

    Morbidity at 90 days (according to Clavien-Dindo and Comprehensive Complication Index, CCI)

    Measured: 90 days

  7. Cancer-related mortality

    Risk of mortality with sole relation to death by tumor progression and

    Measured: 3 and 5 years

  8. Drop out

    Percentage of patients who do not complete the procedure (drop-out) stratified by cause

    Measured: 5 years

  9. Concordance of surgical and PET_RM staging (number, size, location)

    Asses if suspicious lymph nodes described at the preoperative PET-RM confirm to be pathological at the histological evaluation after lymphadenectomy of the hepatic hilum and exploratory laparotomy. Lymph nodes will we evaluated by number, size and location

    Measured: Perioperative

  10. Quality of life assessed using EORTC QLQ-C30

    Quality of life assessed using EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer QLG Core Questionnaire) 30 items questionnaire (scale 1-4 or 1-7, 1 being the lowest and 4 or 7 the highest, accordingly)

    Measured: 5 years

  11. Quality of life assessed using FACT-Hep questionnaire

    Quality of life assessed using FACT-Hep questionnaire (Functional Assessment of Cancer Therapy - Hepatobiliary) questionnaire about quality of life in the last 7 days (scale 0-4, 0 being the lowest and 4 the highest)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start15 Jan 2024
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion1 Nov 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06098547
Sponsor's protocol ID
AOP 3006
Other IDs
LIRICA
Acronym
LIRICA
Status last verified
Jan 2024
First submitted
18 Oct 2023
Last updated
24 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085.

    PubMed 40812353

Questions about this trial

What is this clinical trial studying?

A study testing Liver transplantation in people with Intrahepatic Cholangiocarcinoma, run by Azienda Sanitaria Ospedaliera at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Enrico Gringeri, Prof. (+39 0498218547, enrico.gringeri@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 3 and 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06098547, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in