TAS-102 in Treating Advanced Biliary Tract Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cholangiocarcinoma
- Stage III Gallbladder Cancer AJCC V7
- Stage IIIA Gallbladder Cancer AJCC v7
- Stage IIIB Gallbladder Cancer AJCC v7
- Stage IV Gallbladder Cancer AJCC v7
- Stage IVA Gallbladder Cancer AJCC v7
- Stage IVB Gallbladder Cancer AJCC v7
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Determine the efficacy of trifluridine/tipiracil hydrochloride combination agent TAS-102 (FTD/TPI [TAS-102]) in patients with refractory cholangiocarcinoma using progression-free survival at 16 weeks. SECONDARY OBJECTIVES: I. Assess the safety and tolerability of FTD/TPI (TAS-...
PRIMARY OBJECTIVES: I. Determine the efficacy of trifluridine/tipiracil hydrochloride combination agent TAS-102 (FTD/TPI [TAS-102]) in patients with refractory cholangiocarcinoma using progression-free survival at 16 weeks. SECONDARY OBJECTIVES: I. Assess the safety and tolerability of FTD/TPI (TAS-102) in patients with refractory cholangiocarcinoma through adverse event monitoring. II. Further explore the efficacy of FTD/TPI (TAS-102) in patients with refractory cholangiocarcinoma by overall response rates, progression-free survival, and overall survival. TERTIARY OBJECTIVES: I. Determine if circulating tumor cells (CTCs) or cell-free deoxyribonucleic acid (DNA) (cfDNA) at baseline correlates with prognosis or response to therapy. II. Determine if change in CTCs or cfDNA correlates with efficacy endpoints. III. Determine if different mutational status of the tumor will affect efficacy endpoints. OUTLINE: Patients receive trifluridine/tipiracil hydrochloride combination agent TAS-102 orally (PO) twice daily (BID) on days 1-5 and 8-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 2 years.
Tracking Information
- NCT #
- NCT03278106
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Amit Mahipal Mayo Clinic
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