Stage III Intrahepatic Cholangiocarcinoma AJCC v8 Clinical Trial
Official title:
A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Previously Treated Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma
This phase II trial tests how well sacituzumab govitecan works in treating patients with cholangiocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced), that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a toxic agent, called SN-38. HRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them.
PRIMARY OBJECTIVE: I. To determine anti-tumor activity by overall response rate (ORR). SECONDARY OBJECTIVES: I. To determine treatment safety based on toxicities participants who have received at least one dose of sacituzumab govitecan. II. To determine anti-tumor activity by progression free survival (PFS). III. To determine anti-tumor activity by disease control rate (DCR). IV. To determine overall survival (OS). EXPLORATORY OBJECTIVES: I. To determine if treatment will result in reduction of the circulating tumor deoxyribonucleic acid (DNA) as a measure of therapeutic response. II. To determine relationship between tumor mutational profile (already performed as standard of care next generation sequencing [NGS] based test) to response. OUTLINE: Patients receive sacituzumab govitecan intravenously (IV) over 1-3 hours on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, positron emission tomography (PET)/computed tomography (CT) or magnetic resonance imaging (MRI) scans, and blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days, and every 3 months for up to 24 months. ;
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