Sacituzumab Govitecan for Bile Duct Cancer
Trial Summary
The trial requires that you do not use other anti-cancer or investigational drugs while participating. If you are on high-dose corticosteroids or UGT1A1 inhibitors/inducers, you must stop them at least 2 weeks before starting the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Sacituzumab Govitecan has been tested in humans with various advanced cancers, and common side effects include nausea, low white blood cell count (neutropenia), diarrhea, tiredness, low red blood cell count (anemia), vomiting, hair loss, constipation, rash, decreased appetite, and abdominal pain. These side effects were observed in more than 25% of patients in clinical trials.
12345Sacituzumab Govitecan is unique because it is an antibody-drug conjugate (ADC) that specifically targets Trop-2, a protein found on many cancer cells, to deliver SN-38, a powerful chemotherapy agent, directly to the tumor. This targeted approach may offer a new option for bile duct cancer, which lacks many standard treatments.
24678Eligibility Criteria
This trial is for patients with advanced forms of bile duct cancer, including those whose cancer has spread locally, returned after treatment, or metastasized. Participants must have measurable disease and be able to undergo procedures like biopsies and scans.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sacituzumab govitecan intravenously over 1-3 hours on days 1 and 8 of each 21-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Participant Groups
Sacituzumab Govitecan is already approved in United States, European Union, Canada for the following indications:
- Metastatic triple-negative breast cancer
- Locally advanced or metastatic urothelial cancer (withdrawn)
- Metastatic HR+/HER2- breast cancer
- Metastatic triple-negative breast cancer
- Metastatic triple-negative breast cancer