NCT02878473: LT for iCCA

Liver Transplantation for Early Intrahepatic Cholangiocarcinoma

Terminated Phase 2 Last updated 13 December 2024

What this trial tests

Phase 2 trial testing Deceased donor Liver Transplantation in Intrahepatic Cholangiocarcinoma in 2 participants. Terminated before completion.

Timeline

5 April 2018

Primary endpoint
6 December 2024

6 December 2024

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	5 April 2018
Primary completion	6 December 2024
Estimated completion	6 December 2024
Sites	1 location across Canada

Drugs / interventions tested

• Deceased donor Liver Transplantation

Conditions studied

• Intrahepatic Cholangiocarcinoma — all drugs for Intrahepatic Cholangiocarcinoma →

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 65, any sex, with Intrahepatic Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cholangiocarcinoma - novel biological insights and therapeutic strategies.
   Ilyas SI, Affo S, Goyal L, Lamarca A, et al · · 2023 · cited 156× · PMID 37188899 · DOI 10.1038/s41571-023-00770-1
2. Current Surgical Management of Peri-Hilar and Intra-Hepatic Cholangiocarcinoma.
   Lauterio A, De Carlis R, Centonze L, Buscemi V, et al · · 2021 · cited 59× · PMID 34359560 · DOI 10.3390/cancers13153657
3. Treatment of Intrahepatic Cholangiocarcinoma-A Multidisciplinary Approach.
   Krenzien F, Nevermann N, Krombholz A, Benzing C, et al · · 2022 · cited 49× · PMID 35053523 · DOI 10.3390/cancers14020362
4. Prognostic and Predictive Molecular Markers in Cholangiocarcinoma.
   Pavicevic S, Reichelt S, Uluk D, Lurje I, et al · · 2022 · cited 32× · PMID 35205774 · DOI 10.3390/cancers14041026
5. Surgical Treatment of Intrahepatic Cholangiocarcinoma: Current and Emerging Principles.
   Beal EW, Cloyd JM, Pawlik TM. · · 2020 · cited 32× · PMID 33396821 · DOI 10.3390/jcm10010104
6. New Challenges in the Management of Cholangiocarcinoma: The Role of Liver Transplantation, Locoregional Therapies, and Systemic Therapy.
   Mauro E, Ferrer-Fàbrega J, Sauri T, Soler A, et al · · 2023 · cited 25× · PMID 36831586 · DOI 10.3390/cancers15041244
7. Recent advances in liver transplantation for cancer: The future of transplant oncology.
   Abreu P, Gorgen A, Oldani G, Hibi T, et al · · 2019 · cited 21× · PMID 32039389 · DOI 10.1016/j.jhepr.2019.07.004
8. Management of Intrahepatic Cholangiocarcinoma.
   Kodali S, Shetty A, Shekhar S, Victor DW, et al · · 2021 · cited 18× · PMID 34072277 · DOI 10.3390/jcm10112368