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Hakeem et al. Hepatoma Res 2023;9:38 https://dx.doi.org/10.20517/2394-5079.2023.59 Page 11 of 14

label trial with an expected enrollment of 15 participants. The study started recruitment in June 2020, with
the estimated primary completion date of May 2035. Primary endpoint is to study the OS, and the main
inclusion criteria are unsuitable for LR due to tumour location or underlying liver dysfunction (cirrhosis),
12 months or more time from the diagnosis of iCCA and date of listing for LT, and could have received at
least 6 months of chemotherapy or locoregional therapy .
[51]
The outcomes from these small but prospective studies would help in proving the oncological benefit of LT
in iCCA and the patient selection protocols for the future.

CONCLUSION
The NHSBT LAG pilot proposal for liver transplantation in cirrhotic patients with intrahepatic
cholangiocarcinoma ≤ 2 cm, which has been operational since December 2022, signifies a significant
advancement in the treatment of this cancer. The proposal suggests that patients with biopsy-proven very
early iCCA who meet specific criteria may be suitable candidates for LT, which could ultimately offer a cure
and improve overall outcomes for iCCA. In this paper, the indication for LT in this setting, referral
framework, recipient selection criteria, peri-transplant management, and oncology-specific outcome
measures are described. These elements will be used to evaluate the effectiveness of LT in this context and to
determine its potential benefits or limitations. The results of the pilot programme will demonstrate the
feasibility of LT in this setting. While this proposal may raise questions about equity of access to limited
transplant resources in the UK, it is important to emphasise that the selection process for potential
transplant recipients will be rigorous and the outcomes will be closely monitored. The national registry will
collect the data from the service evaluation study, and the survival outcomes will be assessed and made
public. Transplantation for iCCA should be encouraged but needs to be evaluated as a clinical trial, such as
our pilot programme, in order to understand the tumour biology better and overall improve outcomes with
iCCA.

DECLARATIONS
Authors’ contributions
Participated in literature review, FTWG discussion and voting, article writing and editing, and critical
review: Hakeem AR, Isaac J, Thorburn D, Heaton N, Prasad R, Walmsley M, Morement H, Watson S,
Manas D, Bridgewater J, Hawkins M, Radhakrishna G, Dasari BVM, Attia M, Adair A, Gibbs P, Sharma D,
Oppong K, Albazaz R, Malik H, Snowdon V, Aluvihare V, Crellin A, Valle J, Treanor D, Rushbrook S
The five authors were working group coordinators and contributed equally to the writing of the manuscript:
Hakeem AR, Isaac J, Thorburn D, Heaton N, Prasad R
Agreed with the final version of the manuscript: Hakeem AR, Isaac J, Thorburn D, Heaton N, Prasad R,
Walmsley M, Morement H, Watson S, Manas D, Bridgewater J, Hawkins M, Radhakrishna G, Dasari BVM,
Attia M, Adair A, Gibbs P, Sharma D, Oppong K, Albazaz R, Malik H, Snowdon V, Aluvihare V, Crellin A,
Valle J, Treanor D, Rushbrook S

Availability of data and materials
Not applicable.

Financial support and sponsorship
None.

Conflicts of interest
All authors declared that there are no conflicts of interest.