Clinical Trials List
Protocol NumberTTYTG1709
NCT Number(ClinicalTrials.gov Identfier)NCT04070313
2019-04-15 - 2021-10-31
Phase II
Recruiting4
ICD-10C25.9
Malignant neoplasm of pancreas, unspecified
A phase II study of S-1 Adjuvant Chemotherapy in Patients with Resected Pancreatic Cancer in Taiwan
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Trial Applicant
TTY Biopharm Company Limited
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Sponsor
TTY Biopharm
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 王心儀 Division of General Surgery
- 陳世欽 Division of General Surgery
- Chung-Pin Li Digestive System Department
- Rheun-Chuan Lee Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jen-Shi Chen Division of Hematology & Oncology
- Chun-Nan Yeh Division of General Surgery
- Wen-Chi Chou Division of Hematology & Oncology
- 徐潤德 Division of General Surgery
- 曾振輝 Division of Radiology
- TsanLung Hwang Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Li-Tzong Chen Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- Nai-Jung Chiang Division of Hematology & Oncology
- 姜乃榕 Division of Hematology & Oncology
- 趙盈瑞 Division of General Surgery
- Liu Yi-Sheng Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- SHIH-HUNG YANG Division of Hematology & Oncology
- BANG-BIN CHEN Division of Radiology
- SHIH-HUNG YANG Division of Hematology & Oncology
- 郭庭均 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Resected Pancreatic Cancer
Objectives
To verify the efficacy of S-1 adjuvant chemotherapy in resectable pancreatic cancer.
Primary Endpoint: Relapse-free survival (RFS)
Secondary Endpoints: 2-year survival rate, 2-year relapse-free survival (RFS) rate, safety profile
Test Drug
TS-1® (S-1)
Active Ingredient
tegafur/ Gimeracil / Oteracil potassium
Dosage Form
Capsule
Dosage
20 mg/capsule ; 25 mg/capsule
Endpoints
Primary Outcome Measures :
Relapse-free survival (RFS) [ Time Frame: 2 years ]
The time from registration to the time of initial detection of relapse or death from any causewhichever came first, assessed up to 2 years
Secondary Outcome Measures :
2-year survival rate [ Time Frame: 2 years ]
The number of patient who occur relapse or death from any cause, whichever comes first before end of 2 years
2-year relapse-free survival (RFS) rate [ Time Frame: 2 years ]
the percentage of people in a study who are alive 2 years after their diagnosis or the start of treatment
safety profile [ 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 v5.0 grade
Relapse-free survival (RFS) [ Time Frame: 2 years ]
The time from registration to the time of initial detection of relapse or death from any causewhichever came first, assessed up to 2 years
Secondary Outcome Measures :
2-year survival rate [ Time Frame: 2 years ]
The number of patient who occur relapse or death from any cause, whichever comes first before end of 2 years
2-year relapse-free survival (RFS) rate [ Time Frame: 2 years ]
the percentage of people in a study who are alive 2 years after their diagnosis or the start of treatment
safety profile [ 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 v5.0 grade
Inclution Criteria
Inclusion Criteria:
1) Patients with resected adenocarcinoma pancreatic cancer that was
histologically verified.
2) Patients with macroscopic resection of the primary tumor, and confirmed local
residual tumor classified as R0/R1.
3) Absence of distant metastases and malignant ascites
4) Adequate oral intake
5) Age of 20 years or above
6) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0
or 1
7) Adequate hematopoietic which is defined as below,
White blood cell count: 3,000/mm3, ≤ 12,000/mm3
Platelet count: 100,000/mm3
Hemoglobin: 8.0 g/dL
ANC 1500/mm3
8) CA19-9 ≤ 100 U/mL
9) Absence used of chemotherapy or radiotherapy.
10) Within 10 weeks following resection of pancreatic cancer
11) Written informed consent given
1) Patients with resected adenocarcinoma pancreatic cancer that was
histologically verified.
2) Patients with macroscopic resection of the primary tumor, and confirmed local
residual tumor classified as R0/R1.
3) Absence of distant metastases and malignant ascites
4) Adequate oral intake
5) Age of 20 years or above
6) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0
or 1
7) Adequate hematopoietic which is defined as below,
White blood cell count: 3,000/mm3, ≤ 12,000/mm3
Platelet count: 100,000/mm3
Hemoglobin: 8.0 g/dL
ANC 1500/mm3
8) CA19-9 ≤ 100 U/mL
9) Absence used of chemotherapy or radiotherapy.
10) Within 10 weeks following resection of pancreatic cancer
11) Written informed consent given
Exclusion Criteria
Exclusion Criteria:
1) Patient previous received adjuvant therapy for pancreatic cancer
2) Patient previously received S-1 treatment and concurrent using other
fluoropyrimidine-group anti-cancer drugs, combination therapies with them
(such as folinate plus Tegafur-Uracil combination therapy)
3) Recurrence prior to registration.
4) Moderate or more severe pleural effusion or ascites upon abdominal CT.
5) Inadequate hepatic function which is defined as below:
Total bilirubin greater than 1.5 times the ULN.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
greater than 2.5 times the ULN.
6) Inadequate renal function which is defined as below:
Creatinine clearance rate (CCr) < 60 mL/min
7) Inadequate heart function which is defined as below:
Heart failure of Class III (Marked limitation of physical activity. Comfortable at
rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.) or
Class IV (Unable to carry on any physical activity without discomfort.
Symptoms of heart failure at rest. If any physical activity is undertaken,
discomfort increases.) according to the New York Heart Association functional
classification.
8) Other serious complications such as active peptic ulcer, paresis of intestine or
any others.
9) Pulmonary fibrosis or interstitial pneumonia clearly observed
10) Uncontrolled watery diarrhea.
Whether a patient has diarrhea 4 or more times a day while receiving adequate
supportive therapy will be used as the indicator to determine whether watery
diarrhea is inadequately controlled.
11) Blood transfusion within 2 weeks prior to registration
12) Myocardial infarction within 6 months following documentation of pancreatic
cancer
13) An active infectious disease (pyrexia of 38°C or higher, etc.), including active
Hepatitis B or C.
Active HBV: HBeAg positive or HBeAg negative but HBV DNA > 2000 IU/mL.
Active HCV: Anti-HCV Ab positive
14) Poorly controlled diabetes mellitus:
Fasting blood sugar ≥ 200 mg/dL or HbA1c ≥ 10.0 %
15) Participation in the study by the patient is judged difficult due to a complicating
psychiatric disorder or psychological symptoms
16) Patient is using drainage.
17) Serious drug allergy or hypersensitivity to the ingredients of S-1
18) Other malignancy with the exception of non-melanoma skin cancer or cervical
carcinoma in situ within 5 years prior to registration.
19) Pregnant women or nursing mothers, or positive pregnancy test for women of
childbearing potential. Fertile women of childbearing potential unless using a
reliable and appropriate contraceptive method throughout the treatment period
and for three months following cessation of treatment.
20) Man who is willing to conceive a child during the treatment period.
21) On flucytosine, phenytoin or warfarin potassium treatment.
22) Participation in another clinical trial with any investigational drug within 30
days prior to registration.
23) Patients who were judged to be ineligible as the subjects of this study by the
investigators.
1) Patient previous received adjuvant therapy for pancreatic cancer
2) Patient previously received S-1 treatment and concurrent using other
fluoropyrimidine-group anti-cancer drugs, combination therapies with them
(such as folinate plus Tegafur-Uracil combination therapy)
3) Recurrence prior to registration.
4) Moderate or more severe pleural effusion or ascites upon abdominal CT.
5) Inadequate hepatic function which is defined as below:
Total bilirubin greater than 1.5 times the ULN.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
greater than 2.5 times the ULN.
6) Inadequate renal function which is defined as below:
Creatinine clearance rate (CCr) < 60 mL/min
7) Inadequate heart function which is defined as below:
Heart failure of Class III (Marked limitation of physical activity. Comfortable at
rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.) or
Class IV (Unable to carry on any physical activity without discomfort.
Symptoms of heart failure at rest. If any physical activity is undertaken,
discomfort increases.) according to the New York Heart Association functional
classification.
8) Other serious complications such as active peptic ulcer, paresis of intestine or
any others.
9) Pulmonary fibrosis or interstitial pneumonia clearly observed
10) Uncontrolled watery diarrhea.
Whether a patient has diarrhea 4 or more times a day while receiving adequate
supportive therapy will be used as the indicator to determine whether watery
diarrhea is inadequately controlled.
11) Blood transfusion within 2 weeks prior to registration
12) Myocardial infarction within 6 months following documentation of pancreatic
cancer
13) An active infectious disease (pyrexia of 38°C or higher, etc.), including active
Hepatitis B or C.
Active HBV: HBeAg positive or HBeAg negative but HBV DNA > 2000 IU/mL.
Active HCV: Anti-HCV Ab positive
14) Poorly controlled diabetes mellitus:
Fasting blood sugar ≥ 200 mg/dL or HbA1c ≥ 10.0 %
15) Participation in the study by the patient is judged difficult due to a complicating
psychiatric disorder or psychological symptoms
16) Patient is using drainage.
17) Serious drug allergy or hypersensitivity to the ingredients of S-1
18) Other malignancy with the exception of non-melanoma skin cancer or cervical
carcinoma in situ within 5 years prior to registration.
19) Pregnant women or nursing mothers, or positive pregnancy test for women of
childbearing potential. Fertile women of childbearing potential unless using a
reliable and appropriate contraceptive method throughout the treatment period
and for three months following cessation of treatment.
20) Man who is willing to conceive a child during the treatment period.
21) On flucytosine, phenytoin or warfarin potassium treatment.
22) Participation in another clinical trial with any investigational drug within 30
days prior to registration.
23) Patients who were judged to be ineligible as the subjects of this study by the
investigators.
The Estimated Number of Participants
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Taiwan
46 participants
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Global
46 participants
