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Clinical Trials/NCT06098547
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

Sponsor
Azienda Sanitaria Ospedaliera
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Enrico Gringeri

Associate Professor

Azienda Ospedaliera di Padova

Study Sites (2)

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