Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients

Inclusion Criteria:

1. Signed informed-consent form.

2. Man or woman aged 18 years to 80 years.

3. Histologically confirmed pancreatic carcinoma, and the histological type is ductaladenocarcinoma.

4. Mild (Child-Pugh A), moderate (Child-Pugh B) and some preferable severe (Child-Pugh C, <=10) hepatic dysfunction according to the Child-Pugh Scoring system criteria.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3, with lifeexpectation of no less than 12 weeks.

6. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥1.5 x 109/L; platelets ≥ 70 x 109/L; hemoglobin ≥ 8.0 g/dL.

7. Albumin ≥ 30 g/L.

8. Adequate hepatic function as evidenced by Alanine aminotransferase (ALT) and Aspartateaminotransferase (AST) ≤ 5 x upper limit of normal (ULN); Serum total bilirubin ≤ 1.5x ULN; Serum creatinine ≤ 1.5 x ULN.

9. Females of childbearing potential must have a negative serum pregnancy test and mustnot breast-feed before the first dose. Male also need contraception.

10. Willing and able to comply with study procedures for the duration of the study.

Exclusion Criteria:

1. Hypertension, and unable to drop to normal level (systolic pressure >140 mmHg,diastolic pressure >90 mmHg) after treatment.

2. Patients have active cardiac disease including any of the following:

3. In resting state, average correction QTc > 470 msec on mean value of 3 timesscreening ECGs.

4. Any clinically significant abnormal ECG form, for example, complete left bundlebranch block, 3-degree atrioventricular block, 2-degree atrioventricular block,or PR interval > 250 msec.

5. Any factors may increase the risk of QTc prolongation or arrhythmic event.

6. Left ventricular ejection fraction (LVEF) < 50%.

7. Patient weight still in losing period.

8. History of gastrointestinal bleeding or a gastrointestinal bleeding tendency, such asesophageal varices with high risk of bleeding, local active ulcerative lesions, fecaloccult blood test>= (+ +) within the past 6 months, shall not enter the trial. Iffecal occult blood test (+), the patient is requested for gastroscopy.

9. Patients with abdominal fistula, gastrointestinal perforation or abdominal abscesswithin the past 28 days, should not enter the trial.

10. Patients with coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN

• 4 sec), with bleeding tendency or are treated with thrombolytic or anticoagulanttherapy.

7. Patients with unstable or serious concurrent medical conditions are excluded. Theresearcher evaluates that the patient who is not suitable for participation in thestudy. Patients with active infection, for example, HBV, HCV, or HIV.

8. Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable toswallow drugs, which may affect the fully absorption of S-1.

9. Patients with mental illness, or with psychiatric history of drug abuse.