Recruiting
Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments
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.
ClinicalTrials.gov IDNCT06862934
PhaseNot Applicable
Enrollment14
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
Age18 Years
SexALL
Conditions studied
Intrahepatic Cholangiocarcinoma (Icc)
About this study
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.
Primary outcomes
- 3-year overall survival vs unresectable patients (3 years)
Eligibility information
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
Study locations
- Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Milan 20133 Italy
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.