LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)

Not Applicable

Recruiting

• Conditions: Perihilar Cholangiocarcinoma

• Registration Number: NCT06125769
• Lead Sponsor: Azienda Sanitaria Ospedaliera

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-11-05
• Study First Posted: 2023-11-09
• Status Verified: 2024-01
• Study Start: 2024-01-15
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2028-11-01
• Study Completion: 2033-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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)
• 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)
• Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopic involvement of CBD) or resectable pCCA arising in PSC
• Radial tumor diameter <3 cm
• At least six months have passed since the first diagnosis of pCCA to the date of inclusion on the liver transplant waiting list
• The patient has received at least six months of standard of care (SOC) chemotherapy, achieving disease stability or partial response (according to RECIST criteria version 1.1) at the time of listing for transplantation
• Absence of medical or surgical contraindication to liver transplantation
• 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

Exclusion Criteria

• Diagnosis of intrahepatic cholangiocarcinoma (iCCA)
• Uncontrollable infection
• Prior radiotherapy or chemotherapy
• Prior biliary surgical resection or attempted surgical resection
• Diameter of tumor >3cm
• Presence of intra-hepatic metastases
• Present or past evidence of extrahepatic metastatic disease
• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	3 and 5 years	Survival from time of transplantation to time of death or last follow up

Secondary Outcome Measures

Name	Time	Method
Overall survival comparison with chemotherapy alone	3 years	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)
Morbidity	90 days	Morbidity at 90 days (according to Clavien-Dindo and Comprehensive Complication Index, CCI)
Progression-Free Survival (PFS)	3 and 5 years	Survival from time of transplantation to time of death or first evidence of progression of disease
Overall survival from the time of recurrence	5 years	Survival from time of recurrence to time of death or last follow up
Biological markers	5 years	Correlation of overall survival and recurrence with tissue and circulating biological markers (immunohistochemistry, proteomics, circulating tumor cells, circulating tumor DNA, new molecular markers)
Cancer-related mortality	3 and 5 years	Risk of mortality with sole relation to death by tumor progression
Drop out	5 years	Percentage of patients who do not complete the procedure (drop-out) stratified by cause
Concordance of surgical and PET/MRI staging	Perioperative	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
Quality of life assessed using EORTC QLQ-C30	5 years	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)
Progression-free survival comparison with chemotherapy alone	3 years	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)
Quality of life assessed using FACT-Hep questionnaire	5 years	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)

Trial Locations

Locations (1)

Azienda Ospedale Università di Padova; 🇮🇹 Padova, Italy