Liver Transplant for Stable, Advanced Intrahepatic Cholangiocarcinoma

Official Title

Liver Transplantation in Locally- Advanced, Unresectable, Non-Metastatic Intrahepatic Cholangiocarcinoma Treated With Neoadjuvant Systemic Therapy: A Single-centre, Pilot Study

Summary:

Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is an increasingly common form of primary liver cancer, but patients with this diagnosis are not currently eligible for LT. This study proposes to offer LT as an option to patients with advanced, unresectable iCCA who demonstrate at least 6 months of disease stability /regression while receiving standard chemotherapy. Patients will be referred and screened for study participation if they have achieved 6 months of disease stability. They will be worked up for transplant and if eligible, will be listed. Disease must remain controlled while awaiting transplantation. After transplantation, patients will be followed for disease recurrence and overall survival, while receiving standard post-transplantation followup.

Trial Description

Primary Outcome:

• patient survival

Secondary Outcome:

• disease-free survival
• patient survival

Patients treated with standard of care chemotherapy for unresectable, biopsy-proven intrahepatic cholangiocarcinoma, and who demonstrate stability/regression of disease for a minimum of 6 months, may be eligible for study. Following informed consent and screening, eligible patients with a potential live liver donor (an interested, ABO-compatible individual, without obvious contraindications for donation) will be evaluated for transplantation. During this period, patients will continue to receive chemotherapy and imaging at the usual intervals. Once a patient completes the pre-transplant assessments and is deemed "suitable for transplantation" , the living donor's assessments may begin. If the donor is found suitable, a tentative date will be set for the surgeries. Systemic chemotherapy will be stopped approximately 4 weeks before the surgery date. At that point, the potential recipient will be reimaged (CT scan). Test results, and inclusion and exclusion criteria will be reviewed to ensure the participant remains eligible to proceed to transplant. If these scans reveal any suspicion of tumour infiltration to surrounding tissues, an exploratory laparotomy or endoscopic ultrasound procedure will be scheduled to allow for visual examination and sampling of those tissues. Tissue samples, such as perihilar fat and/or lymph nodes, will be sent to the pathology department for urgent review. If extrahepatic disease is identified, the participant will be excluded from the study and the transplant will not be performed. Any excluded participants will continue to be followed for the study as "drop outs". Otherwise, the donor and recipient surgeries will be performed in the standard fashion and with the preferred technique of the surgeon. The patient and donor will receive standard of care post-operative care. Participants (recipients) will be monitored closely for evidence of tumour recurrence with imaging and blood tests. Results of these tests will be collected until completion of the study follow-up period (5-years after LT). In addition to tumour surveillance, liver transplant status will be assessed at each study timepoint (including graft loss, rejection, liver function tests, and details of immunosuppression). The study will also collect details of any biopsies performed, re-hospitalizations and surgical complications

View this trial on ClinicalTrials.gov