Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments
Recruiting · NCT06862934 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Fondazione IRCCS Istituto Nazionale Tumori di Milano - Milan, Milan, Italy