A Single-Arm Nonrandomized Phase II Study of Liver Transplantation in Locally Advanced Unresectable Non-Metastatic Intrahepatic Cholangiocarcinoma Treated With Neoadjuvant Systemic Therapy
The aim of the current study is to determine the potential efficacy of liver transplantation in the form of patients' overall survival (OS) after neoadjuvant systemic therapy in patients with biologically responsive locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) in comparison to patients historically treated with chemotherapy alone.
• Age ≥18 years of age on the day of consenting to the study.
• Patients must have histologically confirmed diagnosis of locally advanced intrahepatic cholangiocarcinoma
• Confirmed diagnosis of locally advanced unresectable iCCA with no vascular invasion, lymph node, or extrahepatic disease.
• Unresectable disease based on tumor location or underlying liver disease
• Patients must have ≥ 6 months of disease stability or tumor regression on neoadjuvant therapy. In cases in which patients had received second-line therapy, disease must also have been controlled for ≥ 6 months on that regimen.
• Patients who had previous surgical resection for iCCA are eligible if surgery occurred more than 6 months prior to listing, and patients have had ≥ 6 months of disease stability or response on therapy.
• ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A).
• Patients must have organ and marrow function acceptable for liver transplantation per institutional protocol:
• If history of chronic hepatitis B virus (HBV) infection, viral load should be undetectable on suppressive therapy.
• If history of chronic hepatitis C virus (HCV) infection, patients should have undetectable HCV viral load.
• Women of child-bearing years must have contraception plan in place from the time of study enrollment until at least one year following liver transplant.
• Ability to understand and the willingness to sign a written informed consent document
• Meets all other medical and psychosocial criteria for liver transplant
• Demonstrate ability to comply with study procedures