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

Last updated: January 23, 2024
Sponsor: Azienda Sanitaria Ospedaliera
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Abdominal Cancer

Liver Cancer

Treatment

Liver transplantation

Clinical Study ID

NCT06125769
AOP 3007
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of pCCA (transcatheter biopsy or brush cytology, CA 19-9 > 100 mg/mL and/ora mass on cross-sectional imaging with a malignant appearing stricture oncholangiography, or biliary ploidy with a malignant appearing stricture oncholangiography)
  • Disease considered unsuitable for hepatic resection based on tumor location and extentor underlying liver dysfunction
  • Absence of major vascular invasion, extrahepatic disease, or involvement of regionallymph nodes detected on radiological study
  • No evidence of extrahepatic metastatic disease after chest-abdomen-pelvis CT andPET-MR (or PET-CT)
  • Unresectable tumor above cystic duct (pancreatoduodenectomy for microscopicinvolvement 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 ofinclusion 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/localregulations

Exclusion

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 withoutrecurrence
  • Substance abuse and medical, psychological, or social conditions that may interferewith 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 notparticipate in the study

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Liver transplantation
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
November 01, 2033

Connect with a study center

  • Azienda Ospedale Università di Padova

    Padova, 35128
    Italy

    Active - Recruiting

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