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A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer

NCT02425137 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-08-21

No results posted yet for this study

Summary

Primary Objective:

To evaluate disease control rate (DCR) of S-1 in combination with gemcitabine in patients with advanced biliary tract cancer

Secondary Objectives:

* To evaluate overall response rate (ORR)
* To evaluate progression-free survival (PFS)
* To evaluate overall survival (OS)
* To assess the safety profile

Conditions

  • Advanced Biliary Tract Cancer(BTC)

Interventions

DRUG

S-1/Gemcitabine

Eligible patients will receive gemcitabine 800 mg/m2/day on day 1 and S-1 orally 80-120 mg/day (depending on patient's body surface area (BSA)) on day 1 to 10 in a 2-week cycle.

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • National Taiwan University Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • TTY Biopharm

    lead INDUSTRY

Principal Investigators

  • Li-Tzong Chen, M.D. · National Institute of Cacer Research, National Health Research Institiutes

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02425137 on ClinicalTrials.gov