Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

The study hypothesis is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve 3-year overall survival in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma.

It is planned to include 36 patients with locally advanced intrahepatic cholangiocarcinoma, not eligible for initial surgery and without metastases. Participants will be recruited from care facilities in France.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient aged 18 to 65

Uni or pauci nodular (≤ 5 lesions (all lesions are counted, even those less than 1 cm))

Without extrahepatic or lymph node involvement

Technically unresectable R0 according to an expert panel

Disqualifiers

Extrahepatic, vesicular or perihilar cholangiocarcinoma

Tumor infiltration of more than 50% of the liver

Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma

Previous treatment for CCI

Trial design

Design model

Single group

Treatments tested in this trial

  • Liver transplant

    Procedure/Surgery

    follow-up of liver transplant patients after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: liver transplant patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Strategy efficacy : 3 years overall survival

To assess the 3-year overall survival of patients undergoing liver transplantation for stable or downstaged locally advanced intrahepatic cholangiocarcinoma after induction treatment with selective internal radiotherapy and chemotherapy.

Time frame
3 years post-transplant

Secondary outcomes

1

Strategy feasibility 1/2

Number of patients benefiting from the complete strategy implemented

Time frame
Liver transplantation
2

Strategy feasibility 2/2 contraindication to transplantation

Number of patients with radiological tumor progression according to RECIST 1.1 criteria after neoadjuvant treatment contraindicating transplantation

Time frame
Liver transplantation
3

Associated factors with the 3-years overall survival

Socio-demographic and clinico-radio-biological characteristics at baseline and follow-up of living patients 3 years after strategy implementation.

Time frame
3 years after strategy implementation
4

therapeutic efficacy at 3 years

Number of transplant patients alive and free of recurrence at 3 years after strategy implementation, as well as their socio-demographic and clinico-radiobiological characteristics at baseline and follow-up.

Time frame
3 years after strategy implementation

Other outcomes

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