Liver transplantation for patients with advanced bile duct cancer after treatment

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

This observational study investigates the effectiveness of liver transplantation in patients with unresectable intrahepatic cholangiocarcinoma who have achieved sustained tumor control through a combination of chemotherapy, immunotherapy, and transarterial radioembolization. Patients will undergo a series of imaging tests and treatments to downstage their cancer before being evaluated for transplantation eligibility. The study aims to determine if successful downstaging can lead to better outcomes post-transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological diagnosis of iCCA (biopsy-proven tumor)
* Either first diagnosis or post-resection recurrence (occurring ≥ 6 months after resection)
* Unresectability assessment due to tumor location (leading to insufficient live remnant with/out implementation of hypertrophic parenchymal techniques) or underlying liver disease. Non-resectability assessed by an expert surgical team with experience on both resection and transplantation (centralized at INT Milan).
* Age between 18 and 70 years
* No macrovascular tumor invasion (NB: portal vein and/or hepatic vein occlusion from the external tumor compression and classified as "encasement" could be considered after expert radiology review)
* No extrahepatic spread
* Disease stability for at least 6 months
* CA 19-9 \< 200 u/ml at transplant listing in absence of jaundice
* No medical and surgical contraindications to liver transplantation
* Good performance status, Eastern Cooperative Oncology Group (ECOG) 0 or 1
* No concomitant malignancies or history of other malignancies in the previous 5 years
* Written informed consent

Exclusion Criteria:

* Hilar and distal cholangiocarcinoma
* Progression of disease under chemotherapy +/- radiation therapy, assessed with either RECIST, mRECIST or Choi criteria
* Evidence of lymph-nodal metastases
* Evidence of extrahepatic disease
* Prior extrahepatic metastatic disease
* Concomitant malignancies or history of other malignancies in the previous 5 years
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Any reason why, in the opinion of the investigator, the patient should not participate to the study

Where it's running

• Fondazione IRCCS Istituto Nazionale Tumori di Milano
  Milan, Milan, Italy Recruiting

Study contacts

• Study coordinator: Vincenzo Mazzaferro, MD, PhD
• Email: vincenzo.mazzaferro@istitutotumori.mi.it
• Phone: 0223902760

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.