RecruitingNCT06862934
Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments
Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments (iCOLA)
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Enrollment
14 participants
Start Date
Mar 20, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria12
- 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 Criteria8
- 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06862934
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