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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2019-07-01

Brief Summary

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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

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Detailed Description

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BACKGROUND:

1. The incidence of pancreatic cancer in China has been increasing rapidly in recent years，but most of the pancreatic cancer patients are unresectable, whose median survival time were only 6\~9 months.
2. Studies have shown that neoadjuvant therapy improves the quality of surgery in patients with pancreatic cancer，and prolong their life.
3. S-1 is a new generation of oral fluorouracil derivatives ,S-1 single drug as an adjuvant therapy for resectable pancreatic cancer is better than gemcitabine, and has less side effects than gemcitabine. Protein bound paclitaxel is a novel paclitaxel combined of paclitaxel and albumin by nanotechnology , which can extend free survival in patients with advanced pancreatic cancer with less side effects than gemcitabine. So S-1 combined with Paclitaxel-albumin is expected to play an important role in neoadjuvant chemotherapy in Pancreatic cancer, and may improve the rate of R0 resection in patients with unresectable locally advanced pancreatic.

STUDY DESIGN:

S-1 combined with Paclitaxel-albumin

1. S-1:40\~60mg bid, day 1\~14 (S-1: BSA (Body surface area)\<1.25m2, 40mg bid , 1.25m2 ≤ BSA ≤1.5m2, 50mg bid, BSA\>1.5m2, 60mg bid),2 weeks and rest for 1 weeks.
2. Paclitaxel-albumin: 125 mg/m2, intravenous infusion for 30 minutes, Day1 and Day 8.

Repeat every three weeks. for 6 cycles.

Conditions

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Pancreatic Cancer Neoadjuvant Chemotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S-1 combined with Paclitaxel-albumin

S-1 combined with Paclitaxel-albumin S-1:40\~60mg bid, day 1\~14 (S-1: BSA \<1.25m2, 40mg bid , 1.25m2 ≤ BSA ≤1.5m2, 50mg bid, BSA\>1.5m2, 60mg bid， for 2 weeks, rest a week) Paclitaxel-albumin: 125 mg/m2, intravenous infusion for 30 minutes, Day1 and Day 8.

Group Type EXPERIMENTAL

S1,

Intervention Type DRUG

S-1 is a combination of tegafur, gimeracil and oteracil at a molar ratio of 1:0.4:1, and is a new oral fluoropyrimidine anticancer agent shown to be effective for pancreatic cancer. cancer

Paclitaxel-albumin

Intervention Type DRUG

Paclitaxel-albumin is a drug which showed a survival benefit in Pancreatic Cancer when combined with S1

Interventions

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S1,

S-1 is a combination of tegafur, gimeracil and oteracil at a molar ratio of 1:0.4:1, and is a new oral fluoropyrimidine anticancer agent shown to be effective for pancreatic cancer. cancer

Intervention Type DRUG

Paclitaxel-albumin

Paclitaxel-albumin is a drug which showed a survival benefit in Pancreatic Cancer when combined with S1

Intervention Type DRUG

Other Intervention Names

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Gimeracil and Oteracil Porassium Capsules

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No