Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy (RIS-TH)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Liver Transplantation in Locally Advanced Intrahepatic Cholangiocarcinoma

Treatments: Procedure: Liver transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT06910722

APHP220677

Details and patient eligibility

About

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.

Full description

The hypothesis of the study is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve the overall 3-year survival of patients with locally advanced intrahepatic cholangiocarcinoma (unresectable but not metastatic).

All patients over 18 and under 65 years of age with histologically evidence, pauci-nodular (N≤5), locally advanced Intrahepatic cholangiocarcinoma (IHC) without extrahepatic involvement, considered technically unresectable by a panel of experts, eligible for treatment with SIRT, gemcitabine + cisplatin chemotherapy and Liver Transplant (LT).

Following treatment with SIRT + chemotherapy, tumor response or absence of tumor progression will be verified by a morphological workup combining CT-imaging, hepatic MRI and PET-CT.

After exploratory surgery to rule out any contraindications for LT, the patient will be list , with a minimum waiting of 3-month Follow-up will include assesment of Liver graft function, efficiency and tolerance of immunosuppressive therapy.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged 18 to 65

• With histologically documented intrahepatic cholangiocarcinoma (primary diagnosis):

  • 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

• Tumor target > 2 cm

• WHO 0-1

• free and informed consent signed

• highly effective contraception for men and women of childbearing age during study participation up to 2 years post TH

Exclusion criteria

• Extrahepatic, vesicular or perihilar cholangiocarcinoma

• Tumor infiltration of more than 50% of the liver

• Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma

• Previous treatment for CCI

• Cirrhosis ≥ Child B7

• Chronic alcoholism

• Uncontrolled chronic active infections (patients with HBV, HCV or HDV infections may be included if infections are controlled)

• Stage III A, IIIB, IV and V chronic renal failure (glomerular filtration rate 59 ml/min)

• Contraindications to liver transplant

  • Severe untreatable conditions
  • Recent history (less than 5 years) of cancer
  • severe comorbidities
  • Psychiatric or psychological disorders

• Pregnant or breast-feeding women

• Patient under guardianship

• Not affiliated to a Health care system

• Participating in another interventional study or within the exclusion period of a previous study involving the human body

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

liver transplant patients

Experimental group

Description:

Liver transplantation performed after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma.

Treatment:

Procedure: Liver transplant