Liver transplant after SIRT and chemotherapy for locally advanced intrahepatic cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial will enroll 36 adults (18–65) with histologically confirmed, pauci-nodular (≤5 lesions) locally advanced intrahepatic cholangiocarcinoma without extrahepatic disease who are deemed technically unresectable. Participants receive selective internal radiation therapy (SIRT) plus gemcitabine and cisplatin chemotherapy to control or downstage tumors. Tumor response and absence of progression are checked with CT, liver MRI and PET-CT, and eligible patients undergo exploratory surgery before being listed for liver transplantation with a minimum waiting period of three months. Follow-up monitors liver graft function and tolerance/effectiveness of immunosuppressive therapy, with 3-year overall survival as the key outcome.

Why it matters

Who can join: the full rules

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

Where it's running

• Beaujon
  Clichy-sous-Bois, France Recruiting

Study contacts

• Principal investigator: Mohamed Bouattour — Aphp
• Study coordinator: Mohamed BOUATTOUR
• Email: mohamed.bouattour@aphp.fr
• Phone: 1.40.87.56.14

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.