Study on Sacituzumab Govitecan for Treating Advanced Cholangiocarcinoma
Sponsor: University of Kansas Medical Center
ClinicalTrials ID:NCT06178588
This clinical trial is testing how well the drug sacituzumab govitecan works in treating patients with cholangiocarcinoma, a type of bile duct cancer, that is advanced, has returned, or has spread to other parts of the body.
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Program Overview
This study is exploring the effectiveness of sacituzumab govitecan, a targeted therapy, in treating cholangiocarcinoma that is locally advanced, recurrent, or metastatic. Sacituzumab govitecan is a special type of treatment that uses an antibody to deliver a toxic agent directly to cancer cells, specifically targeting TROP2 receptors on the tumor cells to kill them.
Description
The main goal of this study is to see how well sacituzumab govitecan can shrink tumors in patients with advanced cholangiocarcinoma. Researchers will also look at how safe the treatment is and how long patients can live without the cancer getting worse. They will also study the overall survival of patients and how the treatment affects cancer DNA in the blood.
Patients will receive sacituzumab govitecan through an IV on specific days of each treatment cycle, which repeats every 21 days as long as the cancer does not progress or cause unacceptable side effects. Throughout the study, patients will have tumor biopsies, scans, and blood tests to monitor their response to the treatment.
After finishing the treatment, patients will have follow-up visits at 30 days and then every 3 months for up to 2 years to check on their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand the study and agree to participate.
- Men and women aged 18 years or older.
- Must have a performance status score of 0 to 2, indicating good overall health.
- Must have measurable cancer according to specific medical criteria.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Must have advanced, recurrent, or metastatic cholangiocarcinoma that has not responded to at least one previous treatment.
- Must provide a tumor sample for analysis or agree to a biopsy if needed.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Women and men must agree to use effective contraception during the study and for a specified time after treatment.
Exclusion Criteria
- Currently participating in another clinical trial.
- Planning to use other cancer treatments during the study.
- Have not completed previous cancer treatments within a specified time before starting the study drug.
- Have a psychiatric or social condition that would interfere with the study.
- Have a medical condition that would prevent safe participation in the study.
- Are pregnant or breastfeeding.
- Have a genetic condition that increases risk of side effects from the study drug.
- Have a known allergy to the study drug or its components.
- Require high doses of steroids or certain other medications.
- Have an active infection or have not recovered from previous treatment side effects.
- Have untreated or unstable brain metastases.
- Have certain heart conditions or have had a heart attack or severe heart issues recently.
- Have had previous treatment with similar drugs.
- Have another active cancer or a history of cancer within the last 3 years, with some exceptions.
- Have active inflammatory bowel disease or recent gastrointestinal issues.
- Are receiving treatment for an active infection at the start of the study.
- Have a history of HIV, hepatitis B, or hepatitis C with detectable viral load.
- Have active tuberculosis.
- Have had a recent stroke or heart issues.
- Have had recent major surgery or radiation therapy.
- Have received a live vaccine recently.
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