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| Name | Class |
|---|---|
| Istituto Oncologico Veneto IRCCS | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver transplantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Survival from time of transplantation to time of death or last follow up | 3 and 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 years |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrico Gringeri, Prof. | Contact | +39 0498218547 | enrico.gringeri@unipd.it |
| Name | Affiliation | Role |
|---|---|---|
| Enrico Gringeri, Prof. | Azienda Ospedale Università di Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedale Università di Padova | Recruiting | Padova | PADOVA | 35128 | Italy |
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| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D016031 | Liver Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Survival from time of transplantation to time of death or first evidence of progression of disease |
| 3 and 5 years |
| Overall survival from the time of recurrence | Survival from time of recurrence to time of death or last follow up | 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) | 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) | 5 years |
| Morbidity | Morbidity at 90 days (according to Clavien-Dindo and Comprehensive Complication Index, CCI) | 90 days |
| Cancer-related mortality | Risk of mortality with sole relation to death by tumor progression | 3 and 5 years |
| Drop out | Percentage of patients who do not complete the procedure (drop-out) stratified by cause | 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 | 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) | 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) | 5 years |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013505 |
| Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |