Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Cholangiocarcinoma

Klatskin Tumor

Disease Attributes

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

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Sacituzumab govitecan

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Topoisomerase I Inhibitors

Enzyme Inhibitors

Patients receive sacituzumab govitecan 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, PET/CT or MRI scans, and blood sample collection throughout the study.

Biopsy

Biospecimen Collection

Computed Tomography

Magnetic Resonance Imaging

Positron Emission Tomography

Sacituzumab Govitecan

Anup K. Kasi Loknath Kumar

Anup K Kasi Loknath Kumar

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.

Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma

A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Previously Treated Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma

Defined as best response recorded from the start of the treatment until the end of treatment (taking into account any requirement for confirmation).

Measured by computed tomography (CT) (magnetic resonance imaging \[MRI\] if CT contraindicated) Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Will be reported as a proportion with corresponding 90% confidence interval.

Measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Measured by survival curve and the medical record. Will be reported using Kaplan Meier estimates of the median along with a 90% confidence interval.

National Cancer Institute (NCI)

University of Kansas Medical Center

Principal Investigator

Spots Global Cancer Trial Database for locally advanced cholangiocarcinoma