Liver transplantation for patients with advanced bile duct cancer
Neoadjuvant Chemotherapy and Stereotactic Body Radiation Therapy Followed by Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma: pCOLA
This study is testing if liver transplantation can help patients with advanced bile duct cancer who have controlled their disease with treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, durvalumab |
| Locations | 1 site (Milan, Michigan) |
| Trial ID | NCT06986486 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of liver transplantation in patients with unresectable perihilar cholangiocarcinoma who have achieved disease control through a combination of chemotherapy, immunotherapy, and stereotactic body radiation therapy. Eligible patients will undergo a series of treatments aimed at downstaging their cancer before being evaluated for liver transplantation. The study involves careful monitoring and restaging of the disease to ensure stability before transplantation. The goal is to determine if liver transplantation can be a viable option for these patients after successful treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with unresectable perihilar cholangiocarcinoma who meet specific clinical criteria and have no metastases.
Not a fit: Patients with intrahepatic cholangiocarcinoma or those with uncontrolled infections or recent malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment pathway for patients with advanced bile duct cancer, potentially improving survival rates.
How similar studies have performed: While the approach of combining downstaging therapies with liver transplantation is innovative, similar studies have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of unresectable peripheral cholangiocarcinoma arising one centimeter or more above the superior pancreatic margin, with tumor diameter ≤ 3 cm, diagnosed by: * Transcatheter biopsy or brush cytology * CA-19.9 \> 100 mg/ml and/or a mass on cross-sectional imaging with a malignant appearing stricture on cholangiography * Biliary ploidy by FISH with a malignant appearing stricture on cholangiography * Age between 18 years and 70 years * Absence of intra- and extrahepatic metastases * Absence of lymph-nodal metastases at any site * Biliary stenting of all liver districts * No contraindications to liver transplantation * No concomitant malignancies or history of other malignancies in the previous 5 years * Written informed consent Exclusion Criteria: * Intrahepatic cholangiocarcinoma * Uncontrolled infection * Concomitant malignancies or history of other malignancies in the previous 5 years
Where this trial is running
Milan, Michigan
- Fondazione IRCCS Istituto Nazionale Tumori di Milano — Milan, Michigan, Italy (Recruiting)
Study contacts
- Study coordinator: Vincenzo Mazzaferro, MD, PhD
- Email: vincenzo.mazzaferro@istitutotumori.mi.it
- Phone: 0223902760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.