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It was acknowledged by the group that accurate and relevant data collection is fundamental for delivering
and improving services for these new indications. It was felt that the database should include patients
considered but not assessed, assessed for malignancy but not assessed for transplant, and patients assessed
for transplant but not listed due to frailty and fitness. For the data collection and service evaluation, funding
and staffing arrangements will be sought through AMMF, PSC Support, NHSBT research grants and other
external funding applications.

COMMUNICATION STRATEGY
A multi-pronged approach is proposed to provide appropriate information on this new indication to both
patients, families and clinicians. The FTWG recommended the following programme of promotional events
and arrangements for referrers and targeted relevant clinical bodies across the UK to highlight the
endorsement of iCCA as a newly accepted indication for LT.

A series of road shows facilitated by LAG.

NHSBT website.

AMMF, PSC Support, British Liver Trust.

Engagement with BTS, GBIHPBA, BASL, BLTG, BSG, and BASO (via Special Interest Groups in Transplant
Oncology).

ONGOING CLINICAL TRIALS
At present, there are three ongoing trials that seek to investigate the potential for LT for iCCA patients who
are not eligible for LR. These trials separately focus on early iCCA, primary or recurrent iCCA, and locally
advanced diseases necessitating downstaging therapy.

The clinical trial NCT02878473 “Liver Transplantation for the Treatment of Early Stages of Intrahepatic
Cholangiocarcinoma in Cirrhotics” is being conducted in Toronto, Canada at the University Health
Network and in Barcelona, Spain at the Hospital Clinic. The study started recruitment in April 2018, with
the estimated primary completion date of January 2026. The study aims to recruit a total of 30 patients and
the primary outcome measure is the 5-year OS. The eligibility criteria are similar to the UK pilot proposal -
b i o p s y - c o n f i r m e d s i n g l e ≤ 2 c m i C C A , w i t h b a c k g r o u n d c i r r h o s i s , n o t e l i g i b l e f o r
[49]
LR and CA-19-9 ≤ 100 ng/mL .

The clinical trial, NCT04195503 “Liver Transplant for Stable, Advanced Intrahepatic Cholangiocarcinoma”.
The study is being conducted at the University Health Network, Toronto and is designed as a single-group,
open-label trial with an expected enrollment of 10 participants. The study started recruitment in December
2019, with the estimated primary completion date of December 2026. Primary endpoint is 5-year OS. To be
eligible for this study, the patients must have > 6 months of disease stability or tumour regression on
gemcitabine-based therapy and have at least one blood group compatible living donor who has stepped
[50]
forward to donate .

The TESLA trial, NCT04556214 “Liver Transplantation in Locally-advanced, Unresectable, Non-metastatic
Intrahepatic Cholangiocarcinoma treated with neoadjuvant systemic therapy: a Prospective Exploratory
Trial”. The study is being conducted at Oslo University in Norway and is designed as a single-group, open-