CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 +1 moredrug
Likely dose
Trifluridine/tipiracil (TAS-102) given orallyAI-extracted
Key inclusion· 8
  • Histologically confirmed advanced biliary tract cancer (cholangiocarcinoma or gallbladder cancer) with prior progression or intolerance to at least one line of systemic anticancer therapy
  • Measurable disease by imaging
  • ECOG performance status 0 or 1
  • Absolute neutrophil count ≥1500/mm³
Key exclusion· 8
  • Pregnant or nursing persons
  • Immunocompromised state or HIV-positive patients on antiretroviral therapy
  • Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness limiting compliance
  • Other investigational agent for primary neoplasm within 21 days prior to registration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03278106
NCT03278106Phase 2Completed

Phase II Trial of Trifluridine/Tipiracil (FTD/TPI (TAS-102)) in Biliary Tract Cancers

Mayo Clinic·interventional·Posted Sep 11, 2017·Updated Jun 28, 2023

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis and Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 for Cholangiocarcinoma and 6 related conditions. Completed, enrolled 28 participants across 2 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 11, 2017
Enrollment StartOct 20, 2017
Primary CompletionNov 30, 2018
Study CompletionSep 16, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.8 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102drug

Given PO