Perihilar CholangiocarcinomaLITALHICANCT06125769
LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
A study testing Liver transplantation in people with Perihilar Cholangiocarcinoma, run by Azienda Sanitaria Ospedaliera at 1 site in Italy.
Trial summary
LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment 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
- Perihilar 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
- 50 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
- Diagnosis of pCCA (transcatheter biopsy or brush cytology, CA 19-9 > 100 mg/mL and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography, or biliary ploidy with a malignant appearing stricture on cholangiography)
- Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC
- Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes
- No extrahepatic metastatic disease
- Radial tumor diameter ≤3 cm
- At least six months between first diagnosis of pCCA and date of inclusion
- At least six months of SOC chemotherapy, achieving disease stability or partial response
Who cannot join
- Uncontrollable infection
- Prior radiotherapy or chemotherapy
- Prior biliary surgical resection or attempted surgical resection
- Diameter of tumor >3cm
- Presence of intra-hepatic metastases or iCCA
- Present or past evidence of extrahepatic metastatic disease
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- Transperitoneal biopsy (including percutaneous ecography-guided FNA)
- Prior neoplasms, except those treated curatively for more than 5 years without recurrence
- Substance abuse and medical, psychological, or social conditions that may interfere with the patient's participation in the study
- Pregnant or breastfeeding women
- Medical-surgical contraindications for liver transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedale Università di Padova
Padova, PADOVA, 35128
Enrico Gringeri, Prof., +39 0498218547, enrico.gringeri@unipd.it
Enrico Gringeri, Prof.
About this study
LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment 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-MRI, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.
- Conditions
- Perihilar Cholangiocarcinoma
- Being tested
- Liver transplantation
- Keywords
- Liver transplantation
- Medical subject headings
- Klatskin Tumor
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 group | Role | What they receive |
|---|---|---|
| Study population | Experimental | Candidates will be evaluated by a National Multidisciplinary Group after routine radiological studies (CT, MRI, PET-MRI/CT).
Patients will receive 6 months of standard of care chemotherapy and undergo PET-MRI with FDG to exclude the presence of extrahepatic disease.
Following completion of therapy, patients will undergo radiological restaging: those who demonstrate stable disease at this stage are considered eligible for definitive listing for LT. 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.
Overall Survival (OS)
Survival from time of transplantation to time of death or last follow up
Measured: 3 and 5 years
Secondary outcomes (11)
Overall survival comparison with chemotherapy alone
Comparison of 3-year survival between patients enrolled in the LITALHICA 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
Progression-Free Survival (PFS)
Survival from time of transplantation to time of death or first evidence of progression of disease
Measured: 3 and 5 years
Overall survival from the time of recurrence
Survival from time of recurrence to time of death or last follow up
Measured: 5 years
Progression-free survival comparison with chemotherapy alone
Comparison of 3-year progression-free survival between patients enrolled in the LITALHICA study and progression-free survival of a population balanced for prognostic factors and disease characteristics from the database of the Veneto Oncological Institute (IOV)
Measured: 3 years
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
Morbidity
Morbidity at 90 days (according to Clavien-Dindo and Comprehensive Complication Index, CCI)
Measured: 90 days
Cancer-related mortality
Risk of mortality with sole relation to death by tumor progression
Measured: 3 and 5 years
Drop out
Percentage of patients who do not complete the procedure (drop-out) stratified by cause
Measured: 5 years
Concordance of surgical and PET/MRI staging
Asses if lymph nodes described as suspicious at the preoperative PET-MRI confirm to be pathological at the histological evaluation after lymphadenectomy of the hepatic hilum and exploratory laparotomy
Measured: Perioperative
Quality of life assessed using EORTC QLQ-C30
Quality of life assessed using EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer QLQ 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
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.
- First posted9 Nov 2023
- Study start15 Jan 2024
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perihilar CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Ospedaliera
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Oncologico Veneto IRCCS
- Responsible party
- Principal investigator, Enrico Gringeri, Azienda Sanitaria Ospedaliera
- Investigators
- Enrico Gringeri, Prof., Principal investigator, Azienda Ospedale Università di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125769
- Sponsor's protocol ID
- AOP 3007
- Acronym
- LITALHICA
- Status last verified
- Mar 2026
- First submitted
- 30 Oct 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)
- ClinicalTrials.gov ID
- NCT06125769
- Acronym / sponsor ID
- LITALHICA / AOP 3007
- Conditions
- Perihilar Cholangiocarcinoma
- Keywords
- Liver transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Sanitaria OspedalieraUniversity, hospital or other
- Collaborators
- Istituto Oncologico Veneto IRCCS
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2033 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LITALHICA is a prospective non-randomized study aimed at exploring the outcome of liver transplantation in selected patients with unresectable perihilar cholangiocarcinoma (pCCA) after treatment 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-MRI, especially in relation to lymph node locations, by correlating the results with histological examination after hilar lymphadenectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Procedure: Liver transplantationCandidates will be evaluated by a National Multidisciplinary Group after routine radiological studies (CT, MRI, PET-MRI/CT). Patients will receive 6 months of standard of care chemotherapy and undergo PET-MRI with FDG to exclude the presence of extrahepatic disease. Following completion of therapy, patients will undergo radiological restaging: those who demonstrate stable disease at this stage are considered eligible for definitive listing for LT. 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of pCCA (transcatheter biopsy or brush cytology, CA 19-9 > 100 mg/mL and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography, or biliary ploidy with a malignant appearing stricture on cholangiography)
- Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC
- Absence of major vascular invasion, extrahepatic disease, or involvement of regional lymph nodes
- No extrahepatic metastatic disease
- Radial tumor diameter ≤3 cm
Key exclusion criteria (11 listed)
- Uncontrollable infection
- Prior radiotherapy or chemotherapy
- Prior biliary surgical resection or attempted surgical resection
- Diameter of tumor >3cm
- Presence of intra-hepatic metastases or iCCA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantationPatients 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. | Procedure or surgery | Study population |
Primary outcome
Overall Survival (OS)
Time frame: 3 and 5 years
Survival from time of transplantation to time of death or last follow up
11 secondary outcomes
Overall survival comparison with chemotherapy alone
Time frame: 3 years
Progression-Free Survival (PFS)
Time frame: 3 and 5 years
Overall survival from the time of recurrence
Time frame: 5 years
Progression-free survival comparison with chemotherapy alone
Time frame: 3 years
Biological markers
Time frame: 5 years
Morbidity
Time frame: 90 days
Cancer-related mortality
Time frame: 3 and 5 years
Drop out
Time frame: 5 years
Concordance of surgical and PET/MRI staging
Time frame: Perioperative
Quality of life assessed using EORTC QLQ-C30
Time frame: 5 years
Quality of life assessed using FACT-Hep questionnaire
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrico Gringeri, Prof. principal investigator
Azienda Ospedale Università di Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver transplantation in people with Perihilar 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 7 inclusion and 11 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 3 Apr 2026. 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 (OS) (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?
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 3 Apr 2026.