Liver Transplantation for Intrahepatic Cholangiocarcinoma After Chemotherapy and Radioembolization: An Intention-To-Treat Study.
Marianna Maspero, Carlo Sposito, Marco A Bongini...
https://pubmed.ncbi.nlm.nih.gov/39544321Actively Recruiting
Age: 18Years - 70Years
All Genders
ID06862934
Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments (iCOLA)
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-03-06
14
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness of liver transplantation for patients with liver-limited unresectable intrahepatic cholangiocarcinoma who have shown successful and sustained tumor control after downstaging treatments. This observational study focuses on patients with biopsy-confirmed unresectable intrahepatic cholangiocarcinoma and evaluates the role of transplant following tumor control. The study is investigator-driven and academic, aiming to understand survival and recurrence outcomes after transplantation compared to other treatments. Participants undergo a downstaging protocol involving chemotherapy with or without immunotherapy, combined with transarterial radioembolization (TARE) using Yttrium-90. The treatment sequence includes initial chemotherapy cycles, TARE or stereotactic body radiation therapy if TARE is contraindicated, followed by additional chemotherapy cycles. Molecular-targeted therapies may be given if specific gene mutations are identified. After tumor stability is confirmed through imaging and tumor markers, patients may be listed for liver transplantation. Restaging and maintenance therapies continue during the waiting period, with transplant aimed within 90 days of listing. Throughout the study, participants receive regular assessments including CT/MRI scans, FDG-PET, tumor markers, and staging laparoscopy to monitor tumor response and eligibility. Tumor responses are evaluated with established criteria, and disease progression may lead to temporary removal from the transplant list. The study compares 3-year overall survival and recurrence-free survival between transplanted patients and controls with unresectable or resectable tumors. Quality of life and 90-day morbidity are also monitored. Participants remain under observation for up to three years after treatment.
CONDITIONS
Brief Title
Liver Transplantation for Unresectable Intrahepatic Colangiocarcinoma After Sustained Response to Neoadjuvant Treatments
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of intrahepatic cholangiocarcinoma confirmed by biopsy
- First diagnosis or recurrence occurring 6 months or more after resection
- Tumor assessed as unresectable due to location or liver condition by an expert surgical team
- Age between 18 and 70 years
- No macrovascular tumor invasion except possible vessel encasement
- No spread of cancer outside the liver
- Disease stability for at least 6 months
- CA 19-9 tumor marker less than 200 u/ml at transplant listing without jaundice
- No medical or surgical contraindications to liver transplantation
- Good performance status with ECOG 0 or 1
- No other malignancies or cancer history in the last 5 years
- Provided written informed consent
You will not qualify if you...
- Hilar and distal cholangiocarcinoma
- Disease progression during chemotherapy or radiation therapy
- Lymph node metastases present
- Extrahepatic disease or prior metastatic disease outside the liver
- Other malignancies or cancer history in the last 5 years
- Substance abuse or medical, psychological, or social conditions interfering with study participation
- Any other reason deemed by the investigator to prevent study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Downstaging Treatment Observation
Duration - Approximately 4 to 6 months
Participants undergo downstaging treatments including chemotherapy, immunotherapy, and locoregional therapies to control tumor growth before transplant evaluation.
Multiple visits during treatment cycles and imaging assessments
Transplant Screening and Listing
Duration - At least 6 months of tumor stability prior to listing; listing period up to 3 months
Participants who show sustained tumor stability and negative staging undergo transplant screening and are listed for liver transplantation.
Visits every 2 months for restaging assessments
Liver Transplantation
Duration - Transplant and immediate recovery period
Participants receive liver transplantation following successful downstaging and listing.
1 hospital visit for transplant and immediate post-operative care
Post-transplant Follow-up
Duration - Up to 3 years
Participants are monitored after transplantation for tumor recurrence and overall health outcomes.
Regular follow-up visits as determined by clinical care
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, Milan, Italy, 20133
Actively Recruiting
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Research Team
V
Vincenzo Mazzaferro, MD, PhD
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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Published Research Related To This Trial
Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma.
Alex B Blair, Wilson M Alobuia, Manisha Palta...
https://pubmed.ncbi.nlm.nih.gov/40812353