Liver Transplantation for Early Intrahepatic Cholangiocarcinoma

NCT02878473 | Terminated Phase 2 DMC

• 1 other identifier: 17-5306
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is increasingly common in patients with liver cirrhosis, but these patients are denied liver transplantation (LT) by most centres due to historically poor results. Two retrospective evaluations have shown a 5 year survival \~65% in selected patients with an iCCA diagnosis at the pathology of the explanted liver. This suggests that LT can be a curative treatment if applied selectively. This study will evaluate the effectiveness of LT as a treatment for very early iCCA diagnosed in cirrhotic patients who meet the strict selection criteria. Patients with advanced cirrhosis (not candidates for resection) currently have no other curative treatment options. Participants will be allowed bridging therapies prior to receiving transplant. Participants will be followed for 5 years from the time of transplant with patient survival and disease recurrence as outcome measures.

Conditions

Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• 5 year patient survival

  5 years

Secondary Outcomes (1)

• disease recurrence after liver transplantation

  5 years

Study Arms (1)

Liver transplantation

EXPERIMENTAL

The intervention will consist of liver transplantation

Procedure: Deceased donor Liver Transplantation

Interventions

Deceased donor Liver Transplantation PROCEDURE

Deceased donor orthotopic liver transplantation

Liver transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group: 0 or 1 at all times prior to Liver Transplantation
• Absence of cancer-related symptoms
• Liver cirrhosis (any etiology)
• Patient not eligible for liver resection due to poor liver function/portal hypertension
• Biopsy proven "very early" intrahepatic cholangiocarcinoma (iCCA)
• Willing and able to provide written informed consent.
• Negative serum pregnancy test for women of childbearing potential
• Biopsy proven "very early" (single ≤2 cm) iCCa
• No vascular or biliary involvement seen in preoperative imaging
• No extra-hepatic disease seen in preoperative imaging
• Carbohydrate Antigen (CA) 19.9 values are ≤100 ng/mL

You may not qualify if:

• Previous or concurrent cancer (with some exceptions)
• Patients that have had previous liver resection for iCCA and the current tumor is a recurrence.
• Progression of the tumor in size \>3 cm or development of extrahepatic disease.
• Large vessel invasion, defined radiologically.
• Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
• Pulmonary insufficiency
• History of cardiac disease:
• Uncontrolled infection(s)
• Known history of human immunodeficiency virus (HIV) infection.
• History of solid organ transplantation
• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
• Pregnant or breast-feeding patients

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• Sapisochin G, Facciuto M, Rubbia-Brandt L, Marti J, Mehta N, Yao FY, Vibert E, Cherqui D, Grant DR, Hernandez-Alejandro R, Dale CH, Cucchetti A, Pinna A, Hwang S, Lee SG, Agopian VG, Busuttil RW, Rizvi S, Heimbach JK, Montenovo M, Reyes J, Cesaretti M, Soubrane O, Reichman T, Seal J, Kim PT, Klintmalm G, Sposito C, Mazzaferro V, Dutkowski P, Clavien PA, Toso C, Majno P, Kneteman N, Saunders C, Bruix J; iCCA International Consortium. Liver transplantation for "very early" intrahepatic cholangiocarcinoma: International retrospective study supporting a prospective assessment. Hepatology. 2016 Oct;64(4):1178-88. doi: 10.1002/hep.28744. Epub 2016 Aug 24.

  PMID: 27481548 BACKGROUND

• Achurra P, Fernandes E, O'Kane G, Grant R, Cattral M, Sapisochin G. Liver transplantation for intrahepatic cholangiocarcinoma: who, when and how. Curr Opin Organ Transplant. 2024 Apr 1;29(2):161-171. doi: 10.1097/MOT.0000000000001136. Epub 2024 Jan 23.

  PMID: 38258823 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Gonzalo Sapisochin, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Jordi Bruix, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 25, 2016
• Study Start: April 5, 2018
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

CA (1)