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This study is a randomized, open-label, controlled study that will compare the efficacy of S-1 in combination with gemcitabine to gemcitabine alone as adjuvant treatment for patients with surgically resected pancreatic adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine | Active Comparator | Gemcitabine:1000mg/m2,iv 30min,d1, d8,d15 q4w, 6 cycles |
|
| S-1+ Gemcitabine | Experimental | S-1:40~60mg bid,d1~14; (S-1 dosage:BSA <1.25m2,40mg bid,1.25m2≤BSA≤1.5m2,50mg bid,BSA>1.5m2, 60mg bid) Gemcitabine:1000mg/m2,iv 30min,d1, d8 q3w, 8 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1, Gemcitabine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Disease free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | 5 years |
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Inclusion Criteria:
Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
Pancreatic cancer surgical staging: T 1-3, N0-1, M0.
Subject should be able to start treatment no later than 12 weeks postsurgery.
≥18 years of age at the time of signing the informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Acceptable hematology parameters:
Exclusion Criteria:
1).History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa) 2).History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies 3).History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
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| Name | Affiliation | Role |
|---|---|---|
| Weijia fang, MD | First Affiliated Hospital,Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First affiliated hospital, Zhejiang University | Hangzhou | Zhejiang | 310006 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |