Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments

Recruiting now

Conditions studied: Intrahepatic Cholangiocarcinoma (Icc)

In brief

This is single-arm, observational, academic, investigator-driven study investigating the efficacy of liver transplantation after successful and sustained downstaging/tumor control of liver-limited unresectable intrahepatic cholangiocarcinoma. The downstaging protocol includes chemotherapy +/- immunotherapy and transarterial radioembolization (TARE) with Yttrium-90 in various combinations.

Key facts

Study ID: NCT06862934
Run by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
People needed: 14
Starts: 2025-03-20
Expected to finish: 2027-12-31
Last updated by the study team: 2025-03-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Fondazione IRCCS Istituto Nazionale Tumori di Milano — Milan, Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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