Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments (iCOLA)

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Nazionale Tumori di Milano
RECRUITING
Milan
Contact Information
Primary
Vincenzo Mazzaferro, MD, PhD
vincenzo.mazzaferro@istitutotumori.mi.it
0223902760
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 14
Treatments
Transplant
Patients enrolled within the study who undergo downstaging and liver transplantation after with various combinations of chemotherapy +/- immunotherapy and TARE
Controls 1 (unresectable)
Historical controls with the same inclusion criteria as the iCOLA protocol, treated with systemic and locoregional therapies and prospectively recruited patients with tumor response who refused transplantation or were not found eligible to LT for medical/non-oncological conditions
Controls 2 (resectable)
Patients with resectable iCC who underwent curative-intent liver resection, matched to the transplanted patients using demographic characteristics, tumor burden and pre-surgical therapies
Sponsors
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov