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

August 20, 2019 updated by: TTY Biopharm

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Linkou, Taiwan
        • Chang Gung memorial hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.histologically confirmed biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, gallbladder, and ampulla of vater);
  • 2.metastatic or unresectable disease;
  • 3.no history of chemotherapy or radiotherapy for biliary tract cancer;
  • 4.presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be ≥15 mm in the short axis;

  • 5.adequate hematopoietic function which is defined as below:

    1. hemoglobin level ≥ 9 g/dL;
    2. absolute neutrophil count (ANC) ≥ 1,500/mm3;
    3. platelet count ≥ 100,000/mm3;

  • 6.adequate hepatic function which is defined as below:

    1. total bilirubin ≤ 1.5 times upper limit of normal (ULN) and < 2 mg/dL, or total bilirubin < 3 mg/dL if biliary drainage was performed;
    2. Alanine aminotransferase (ALT) ≤ 3 x ULN or ALT ≤ 5 x ULN in the presence of liver metastasis;
  • 7.adequate renal function: creatinine clearance rate (CCr) ≥ 60 mL/min ((based upon 24-hour urine collection or calculated by Cockroft-Gault formula);
  • 8.age of 20 years or above;
  • 9.ECOG performance status 0-1;
  • 10.life expectancy of at least 12 weeks;
  • 11.ability to take oral medication;
  • 12.ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • 1.other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
  • 2.history or known presence of brain metastasis;
  • 3.presence of grade 2 or above ascites or pleural effusion;
  • 4.presence of grade 2 or above diarrhea;
  • 5.presence of mental disease or psychotic manifestation;
  • 6.active or uncontrolled infection;
  • 7.significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
  • 8.pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: S-1/Gemcitabine
single-arm
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.
Other Names:
  • TS-1/Gemmis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: 2 years
Disease control is defined as having confirmed complete or partial response or stable disease
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 2 years
To assess Objective response rate (ORR)
2 years
progression-free survival (PFS)
Time Frame: 2 years
To assess progression-free survival (PFS)
2 years
overall survival (OS)
Time Frame: 2 years
To assess overall survival (OS)
2 years
safety profile (percentage of patients with at least one occurrence of preferred term will be included,according to the most severe NCI-CTCAE v4.03 grade)
Time Frame: 2 years
The incidence and percentage of patients with at least one occurrence of preferred term will be included,according to the most severe NCI-CTCAE v4.03 grade
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TTY Biopharm

Collaborators

National Taiwan University Hospital
Chang Gung Memorial Hospital
Taipei Veterans General Hospital, Taiwan
National Cheng-Kung University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (ESTIMATE)

April 23, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTYTG1308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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