Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
About this trial
This is multicentric, single-arm, observational, investigator-drive study investigating the efficacy of liver transplantation after successful downstaging/disease control of unresectable perihilar cholangiocarcinoma using chemotherapy +/- immunotherapy and stereotactic body radiation therapy (SBRT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Transcatheter biopsy or brush cytology
CA-19.9 > 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography
Biliary ploidy by FISH with a malignant appearing stricture on cholangiography
Age between 18 years and 70 years
Disqualifiers
Intrahepatic cholangiocarcinoma
Uncontrolled infection
Concomitant malignancies or history of other malignancies in the previous 5 years
Trial population
Patients with liver-limited unresectable perihilar cholangiocarcinoma with no other non-oncological contraindication to liver transplantation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
8 Participants
are grouped into 1 trial groupGroup A: Transplant
Trial outcomes
Primary outcomes
1
3-year overall survival
To evaluate overall survival at 36 months in patients with unresectable hilar cholangiocarcinoma treated with neoadjuvant chemotherapy and SBRT followed by liver transplantation according to the modified Mayo Clinic protocol
Time frame
3 yearsSecondary outcomes
1
3-year recurrence-free survival
To evaluate recurrence-free survival at 36 months in patients with unresectable hilar cholangiocarcinoma treated with neoadjuvant chemotherapy and SBRT followed by liver transplantation according to the modified Mayo Clinic protocol
Time frame
3 years2
Safety and feasibility
To evaluate the safety and feasibility of neoadjuvant SBRT and chemotherapy in patients with unresectable hilar cholangiocarcinoma candidate to liver transplantation, in particular we will describe in detail the therapeutic path of all patients with unresectable pCCA that enter within the downstaging pathway and are evaluated for LT, how many are able to be transplanted within this protocol, and what are the reasons for dropout from the protocol
Time frame
3 years3
Quality of life
To evaluate the impact of this treatment strategy and of LT on quality of life in patients with unresectable pCCA. Quality of life will be assessed with validated questionnaires. Questionnaires will be performed at baseline and at 6 months intervals; they will be matched and compared with that of eligible patients recruited within the same study period and receiving non-transplant treatments
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov