Trial of Neoadjuvant Chemotherapy With S1 Plus Paclitaxel-albumin on Pancreatic Cancer

• Status: Terminated
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is to evaluate the R0 resection rate of patients with unresectable locally advanced pancreatic cancer ,after treated with S-1 plus Paclitaxel-albumin as neoadjuvant chemotherapy protocols

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Provincial People's Hospital; Zhejiang Provincial People’s Hospital
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

1. Confirmed invasive ductal adenocarcinoma of pancreas by histology

2. Evaluated as CT4N0M0 pancreatic cancer patients by Image testing

3. Adults age from 18-80 years old

4. No history of pancreatic resection or pancreatic cancer

5. ECOG score 0-1; can be orally administered

6. No distant metastasis or malignant ascites

7. Relatively good liver、 kidney、heart、hematology function. Baseline blood routine and biochemical indexes of the subjects meet the following criteria: hemoglobin ≥90g/L;absolute neutrophil count(ANC)≥3.5×109/L；Platelet≥100×109/L;prothrombin time ≤1.8;partial thromboplastin time ≤1.8; ALT≤102U/L、AST≤95U/L; ALP≤2.5 times the upper limits of normal; Serum total bilirubin≤2.5 g/dL(total bilirubin ≤1.5 times the upper limit of normal (ULN)；Serum creatinine≤2.0 mg/dL； creatinine clearance rate >50 ml/min

8. Sign the Informed consent -

Exclusion Criteria:

1. Woman in pregnant or lactation period

2. Woman of childbearing age who was positive at baseline pregnancy test or did not have pregnancy tests.Menopausal women must have menopause for at least 12 months before they think they are free of pregnancy.

3. Men and women who had sexual life (Fertility possibility) were reluctant to have contraception during the study period.

4. Patients with the history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ.

5. Patients of uncontrolled epilepsy, central nervous system diseases or history of mental disorders, should be judged by the researchers whether their clinical severity hinder the signature of the informed consent or influenced patients'compliance with oral medications

6. Clinically serious (i.e. activity) heart disease, such as symptomatic coronary heart disease , New York Heart Association (NYHA) class II or more serious congestive heart failure or serious arrhythmia which need drug intervention, or have a history of MI within the last 12 months.

7. Patients with upper gastrointestinal obstruction or Abnormal physiological function or Malabsorption syndrome, which may affect the absorption of S-1.

8. Organ transplant patients who need immunosuppressive therapy

9. Patients with Serious uncontrolled repeated infection or other serious uncontrolled Concomitant disease.

10. Patient that is lack of dihydropyrimidine dehydrogenase (DPD)

11. Allergic to any of the drug ingredients in this study

12. participate in other clinical trials within 4 weeks before randomization -