Actively Recruiting
Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-05-23
8
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness of liver transplantation after successful disease control in patients with unresectable perihilar cholangiocarcinoma (pCCA). This observational study focuses on patients who have undergone chemotherapy with or without immunotherapy and stereotactic body radiation therapy (SBRT) to downstage their cancer. The study aims to better understand outcomes following this treatment approach, including survival and quality of life over three years. Participants with unresectable pCCA who meet the criteria will first have staging laparoscopy with lymph node sampling. If no spread of disease is found, they will receive two cycles of gemcitabine-cisplatin chemotherapy with or without durvalumab, followed by SBRT, then at least four more cycles of chemotherapy with or without immunotherapy. Disease status will be reassessed, and if stable, patients will undergo transplant screening and be listed for liver transplantation. During listing, restaging with imaging and molecular tests will occur every two months, aiming for transplant within 90 days. Throughout the study, participants will be monitored with CT, MRI, molecular markers, and PET scans to assess disease stability and safety. Researchers will measure overall survival, recurrence-free survival, safety, feasibility, and quality of life over three years. Treatment with chemotherapy and immunotherapy will continue until transplant, disease progression, or unacceptable side effects. The study will follow participants until January 2030.
CONDITIONS
Brief Title
Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of unresectable perihilar cholangiocarcinoma arising at least one centimeter above the superior pancreatic margin, with tumor diameter 3 cm or less
- Diagnosis confirmed by transcatheter biopsy, brush cytology, elevated CA-19.9, imaging with malignant stricture on cholangiography, or biliary ploidy by FISH with malignant stricture
- Age between 18 and 70 years
- No intrahepatic or extrahepatic metastases
- No lymph-node metastases at any site
- Biliary stenting of all liver districts
- No contraindications to liver transplantation
- No other malignancies currently or within the past 5 years
- Written informed consent
You will not qualify if you...
- Intrahepatic cholangiocarcinoma
- Uncontrolled infection
- Other malignancies currently or within the past 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 2 weeks
Participants undergo staging laparoscopy with nodal sampling and peritoneal washing to confirm eligibility and disease status.
1 to 2 visits (in-person)
Duration - Multiple cycles over several months until liver transplant or discontinuation
Participants receive downstaging treatment with gemcitabine-cisplatin with or without durvalumab, followed by stereotactic body radiation therapy (SBRT), then additional chemotherapy cycles until liver transplant, disease progression, or unacceptable toxicity.
Regular visits for chemotherapy and SBRT sessions as scheduled
Duration - Up to 3 months between listing and transplant
Participants undergo disease restaging and transplant screening, including imaging and molecular marker assessments every two months while listed for transplant.
Visits every 2 months for imaging and assessments
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, Michigan, Italy, 20133
Actively Recruiting
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
1
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