NCT06098547RecruitingNot Applicable
LIver Transplantation for Non-Resectable Intrahepatic CholAngiocarcinoma (LIRICA)
Azienda Sanitaria Ospedaliera2 sites in 1 country10 target enrollmentStarted: January 15, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Overall Survival
Study Overview
Brief 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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
- •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
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 3 and 5 years
Survival from time of transplantation to time of death or last follow up
Secondary Outcomes
- PFS comparison with chemotherapy alone(3 years)
- OS comparison with chemotherapy alone(3 years)
- Disease-Free Survival (DFS)(3 and 5 years)
- Concordance of surgical and PET_RM staging (number, size, location)(Perioperative)
- Quality of life assessed using EORTC QLQ-C30(5 years)
- Biological markers(5 years)
- Overall survival from the time of recurrence(5 years)
- Cancer-related mortality(3 and 5 years)
- Morbidity(90 days)
- Drop out(5 years)
- Quality of life assessed using FACT-Hep questionnaire(5 years)
Investigators
Enrico Gringeri
Associate Professor
Azienda Ospedaliera di Padova
Study Sites (2)
Loading locations...
Similar Trials
Recruiting
Not Applicable
LIver TrAnspLantation for Non-resectable Peri-HIlar cholangioCArcinoma (LITALHICA)Perihilar CholangiocarcinomaNCT06125769Azienda Sanitaria Ospedaliera50
Recruiting
Not Applicable
Liver Transplantation for Non-Resectable Intrahepatic Cholangiocarcinoma: a Prospective Exploratory Trial (TESLA Trial)Intrahepatic CholangiocarcinomaNCT04556214Oslo University Hospital15
Recruiting
Not Applicable
Liver Transplantation for Non-resectable Perihilar CholangiocarcinomaPerihilar CholangiocarcinomaKlatskin TumorBile Duct CancerNCT04993131Oslo University Hospital15
Recruiting
Not Applicable
Liver Transplantation in Intrahepatic CholangiocarcinomaCholangiocarcinoma, IntrahepaticIntrahepatic CholangiocarcinomaNCT06140134Rutgers, The State University of New Jersey30
Recruiting
Not Applicable
Liver Transplantation for Non-Resectable Colorectal Liver MetastasisLiver Metastasis Colon CancerColorectal CancerNCT05185245IRCCS Azienda Ospedaliero-Universitaria di Bologna20