A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer
1 other identifier
interventional
51
1 country
4
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedAugust 21, 2019
July 1, 2017
2.1 years
March 26, 2015
August 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Disease control rate (DCR)
Disease control is defined as having confirmed complete or partial response or stable disease
2 years
Secondary Outcomes (4)
Objective response rate (ORR)
2 years
progression-free survival (PFS)
2 years
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)
2 years
Study Arms (1)
S-1/Gemcitabine
EXPERIMENTALsingle-arm
Interventions
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.
Eligibility Criteria
You may qualify if:
- histologically confirmed biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, gallbladder, and ampulla of vater);
- metastatic or unresectable disease;
- no history of chemotherapy or radiotherapy for biliary tract cancer;
- 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;
- adequate hematopoietic function which is defined as below:
- hemoglobin level ≥ 9 g/dL;
- absolute neutrophil count (ANC) ≥ 1,500/mm3;
- platelet count ≥ 100,000/mm3;
- 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;
- adequate renal function: creatinine clearance rate (CCr) ≥ 60 mL/min ((based upon 24-hour urine collection or calculated by Cockroft-Gault formula);
- age of 20 years or above;
- ECOG performance status 0-1;
- life expectancy of at least 12 weeks;
- +2 more criteria
You may not qualify if:
- other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
- history or known presence of brain metastasis;
- presence of grade 2 or above ascites or pleural effusion;
- presence of grade 2 or above diarrhea;
- presence of mental disease or psychotic manifestation;
- active or uncontrolled infection;
- significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TTY Biopharmlead
- National Cheng-Kung University Hospitalcollaborator
- National Taiwan University Hospitalcollaborator
- Taipei Veterans General Hospital, Taiwancollaborator
- Chang Gung Memorial Hospitalcollaborator
Study Sites (4)
Chang Gung Memorial Hospital
Linkou District, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Related Publications (2)
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.
PMID: 23763511RESULTChiang 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.
PMID: 32463975DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Li-Tzong Chen, M.D.
National Institute of Cacer Research, National Health Research Institiutes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
April 23, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
August 21, 2019
Record last verified: 2017-07