Advanced Biliary Tract Cancer(BTC)Phase 2NCT02425137
A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer
A Phase 2 study testing S-1/Gemcitabine in people with Advanced Biliary Tract Cancer(BTC), run by TTY Biopharm at 4 sites in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Biliary Tract Cancer(BTC)
- What is being tested?
- S-1/Gemcitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesTaiwan
- Study dates
- Apr 2015to May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- hemoglobin level ≥ 9 g/dL;
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- absolute neutrophil count (ANC) ≥ 1,500/mm3;
- platelet count ≥ 100,000/mm3;
- 6.adequate hepatic function which is defined as below:
- 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;
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Chang Gung Memorial Hospital
Linkou District
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei
About this study
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)
- Being tested
- S-1/Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1/GemcitabineDrug
Also called TS-1/Gemmis
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.
| Study group | Role | What they receive |
|---|---|---|
| S-1/Gemcitabine | Experimental | single-arm Receives: Drug: S-1/Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR)
Disease control is defined as having confirmed complete or partial response or stable disease
Measured: 2 years
Secondary outcomes (4)
Objective response rate (ORR)
To assess Objective response rate (ORR)
Measured: 2 years
progression-free survival (PFS)
To assess progression-free survival (PFS)
Measured: 2 years
overall survival (OS)
To assess overall survival (OS)
Measured: 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)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Biliary Tract Cancer(BTC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- TTY Biopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cheng-Kung University Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Li-Tzong Chen, M.D., Principal investigator, National Institute of Cacer Research, National Health Research Institiutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425137
- Sponsor's protocol ID
- TTYTG1308
- Status last verified
- Jul 2017
- First submitted
- 26 Mar 2015
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Morizane C, Okusaka T, Mizusawa J, Takashima A, Ueno M, Ikeda M, Hamamoto Y, Ishii H, Boku N, Furuse J. Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: a Japan Clinical Oncology Group trial (JCOG 0805). Cancer Sci. 2013 Sep;104(9):1211-6. doi: 10.1111/cas.12218. Epub 2013 Jul 25.
PubMed 23763511Chiang NJ, Chen MH, Yang SH, Hsu C, Yen CJ, Tsou HH, Su YY, Chen JS, Shan YS, Chen LT. Multicentre, phase II study of gemcitabine and S-1 in patients with advanced biliary tract cancer: TG1308 study. Liver Int. 2020 Oct;40(10):2535-2543. doi: 10.1111/liv.14538. Epub 2020 Jun 9.
PubMed 32463975
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT02425137
- Acronym / sponsor ID
- TTYTG1308
- Conditions
- Advanced Biliary Tract Cancer(BTC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- TTY BiopharmIndustry (pharma, biotech, devices)
- Collaborators
- National Cheng-Kung University Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital
- Study start
- Apr 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-1/Gemcitabine | Experimental | Drug: S-1/Gemcitabinesingle-arm |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1/GemcitabineAlso: TS-1/GemmisEligible 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. | Drug | S-1/Gemcitabine |
Primary outcome
Disease control rate (DCR)
Time frame: 2 years
Disease control is defined as having confirmed complete or partial response or stable disease
4 secondary outcomes
Objective response rate (ORR)
Time frame: 2 years
progression-free survival (PFS)
Time frame: 2 years
overall survival (OS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Results publication: PubMed 23763511Morizane C, Okusaka T, Mizusawa J, Takashima A, Ueno M, Ikeda M, Hamamoto Y, Ishii H, Boku N, Furuse J. Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: a Japan Clinical Oncology Group trial (JCOG 0805). Cancer Sci. 2013 Sep;104(9):1211-6. doi: 10.1111/cas.12218. Epub 2013 Jul 25.
- Derived from this study: PubMed 32463975Chiang NJ, Chen MH, Yang SH, Hsu C, Yen CJ, Tsou HH, Su YY, Chen JS, Shan YS, Chen LT. Multicentre, phase II study of gemcitabine and S-1 in patients with advanced biliary tract cancer: TG1308 study. Liver Int. 2020 Oct;40(10):2535-2543. doi: 10.1111/liv.14538. Epub 2020 Jun 9.
- TFDALink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Tzong Chen, M.D. principal investigator
National Institute of Cacer Research, National Health Research Institiutes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1/Gemcitabine in people with Advanced Biliary Tract Cancer(BTC), run by TTY Biopharm at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02425137, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.