Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine/tipiracil (FTD/TPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD/TPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).
Participants must have histologically or cytologically confirmed biliary tract cancer (BTC) including cholangiocarcinoma and gallbladder carcinoma. Individuals with ampullary cancers will not be considered eligible. Cancer must be advanced stage or metastatic.
Participants must have received only one line of systemic therapy for advanced or metastatic BTCs.
Note: Individuals who have either progressed or are intolerant to the prior therapy can be included in this study.
Age >18 years on day of signing informed consent. Because no dosing or adverse event data are currently available on the use of FTD/TPI in individuals ≤18 years of age, children are excluded from this study.
Participants receiving any other investigational agents.
Participant has received investigational therapy within 4 weeks or within 5 half-lives of the therapeutic agent (whichever is shorter).
Received more than one line of systemic therapy for bile duct cancer. Adjuvant therapy will not be counted as line of systemic therapy.
Receiving systemic steroid therapy (>10mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Single group
Trifluridine/tipiracil
DrugFTD/TPI will be taken by mouth on Days 1-5 of the 14-day treatment cycle. The starting does is 25mg/m2 twice per day.
Oxaliplatin
DrugOxaliplatin is given on Day 1 of each 14-day cycle. It is given intravenously (by IV) over 2 hours.
Disease control rate (DCR) by RECIST v1.1
DCR is the percentage of participants whose cancer did not get worse after treatment (i.e. the percentage of participants who had CR, PR, or SD, as defined below), and this will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Safety and tolerability
Measured by the grade of adverse events (AEs) per CTCAE version 5.0
Safety and tolerability
Measured by the grade of adverse events (AEs) per CTCAE version 5.0
Safety and tolerability
Measured by the grade of adverse events (AEs) per CTCAE version 5.0
Safety and tolerability
Measured by the incidence of adverse events (AEs)
Click on the lead sponsor to view all of their trials.
Case Comprehensive Cancer Center
Lead sponsor
National Comprehensive Cancer Network
Collaborator
