Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT06862934
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06862934
Study Brief:
Protocol Section:
NCT06862934