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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.
Details
| Lead sponsor | Rutgers, The State University of New Jersey |
|---|---|
| Status | RECRUITING |
| Enrolment | 30 |
| Start date | 2023-12-15 |
| Completion | 2029-11 |
Conditions
- Intrahepatic Cholangiocarcinoma
- Cholangiocarcinoma, Intrahepatic
Interventions
- Liver Transplant
Primary outcomes
- 5-year Overall Survival Rate (ORS) — 5 years from the time of transplant or until death of patient, whichever came first
5-year ORS is the length of time that patients diagnosed with locally advanced non-metastatic intrahepatic cholangiocarcinoma (iCCA) treated with neoadjuvant systemic therapy followed by liver transplant (LT) are still alive post-LT.
Countries
United States