Actively Recruiting
Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-03-06
14
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-proven intrahepatic cholangiocarcinoma (iCCA)
- First diagnosis or recurrence occurring 6 months or more after resection
- Tumor deemed unresectable due to location or underlying liver disease by experienced surgical team
- Age between 18 and 70 years
- No macrovascular tumor invasion (except possible encasement after expert review)
- No spread outside the liver
- Disease stability for at least 6 months
- CA 19-9 level below 200 u/ml at transplant listing without jaundice
- No medical or surgical contraindications to liver transplantation
- Good performance status (ECOG 0 or 1)
- No other cancers or history of other cancers in last 5 years
- Provided written informed consent
You will not qualify if you...
- Hilar or distal cholangiocarcinoma
- Disease progression during chemotherapy or radiation therapy
- Evidence of lymph node metastases
- Evidence of cancer outside the liver
- Prior history of metastatic disease outside the liver
- Other cancers or history of other cancers in last 5 years
- Substance abuse or medical, psychological, or social issues interfering with study participation
- Any reason deemed by investigator to exclude the patient from the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, Milan, Italy, 20133
Actively Recruiting
Research Team
V
Vincenzo Mazzaferro, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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