TAS-102 in Treating Advanced Biliary Tract Cancers

Status Completed

Clinical Trial Summary

This phase II trial studies how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) works in treating participants with biliary tract cancers that have spread to other places in the body. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Clinical Trial 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-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. ;

Study Design

Related Conditions & MeSH terms

Biliary Tract Neoplasms
Cholangiocarcinoma
Gallbladder Neoplasms
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

Clinical Trial Details

NCT number	NCT03278106
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	Phase 2
Start date	October 20, 2017
Completion date	September 16, 2021

View Details

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