Clinical Trials List
2014-11-01 - 2016-10-31
Phase II
Terminated4
ICD-10C24.9
Malignant neoplasm of biliary tract, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9156.9
Malignant neoplasm of biliary tract, part unspecified
A study of S-1 in combination with gemcitabine as first-line treatment in patients with advanced biliary tract cancer
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Trial Applicant
TTY Biopharm Company Limited
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Sponsor
TTY BIOPHARM COMPANY LIMITED
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chung-Pin Li Digestive System Department
- Ming-Huang Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Wen-Chi Shen Division of Hematology & Oncology
- 曾振輝 Division of Hematology & Oncology
- Hung-Chih Hsu Division of Hematology & Oncology
- Tsai-Sheng Yang Division of Hematology & Oncology
- Yung-Chia Kao Division of Hematology & Oncology
- Wen-Chi Chou Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Li-Tzong Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Chih-Hung Hsu Division of Hematology & Oncology
- YU-YUN SHAO Division of Hematology & Oncology
- 林宗哲 Division of Hematology & Oncology
- 呂理駿 Division of Hematology & Oncology
- SHIH-HUNG YANG Division of Hematology & Oncology
- SHIH-HUNG YANG Division of Hematology & Oncology
- 林育麟 Division of Hematology & Oncology
- 王秀伯 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Overall response rate (ORR)
Progression-free survival (PFS)
Overall survival (OS)
Safety profile
Inclution Criteria
To be eligible for inclusion, each subject must fulfill all of the following
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:
a. hemoglobin level ≥ 9 g/dL;
b. absolute neutrophil count (ANC) ≥ 1,500/mm3;
c. platelet count ≥ 100,000/mm3
;
6. adequate hepatic function which is defined as below:
a. 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;
b. 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);
< Cockroft-Gault formula >
Male: ((140 - age) × weight [kg])/(72 × serum creatinine[mg/dL])
Female: 0.85 x estimate for male
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
Subjects who fulfill any of the following criteria will be excluded from
the trial:
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.
The Estimated Number of Participants
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Taiwan
46 participants
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Global
46 participants
