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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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 is a drug which showed a survival benefit in Pancreatic Cancer when combined with S1
Zhejiang procincial people's hospital
Hanzhou, Zhejiang, China
R0 resection rate
Evaluate the R0 resection rate of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
Time frame: one week After the operation
The objective remission rate (ORR)
Evaluate the objective remission rate (ORR) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
Time frame: at the end of cycle 6 of the neoadjuvant chemotherapy((each cycle is 21 days)
The disease free survival (DFS)
Evaluate the disease free survival (DFS) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months. Progressing should be confirmed by imaging examination or histology / cytology examination.
The 2 year and 5 year survival rate
Evaluate the 2 year and 5 year survival rate of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
Time frame: 2 years and 5 years after treatment
The quality of life
Assess the quality of life in pancreatic cancer according to EORTC QLQ-PAN26(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreas 26).For each assessment item, there are four options, scores are as 1,2,3,4. Each score corresponds to a physical condition. Then have the total score for each patient. The total score range from 26-104, the higher the score, the poorer the quality of life is.
Time frame: Questionnaire at baseline, and then 1-2 days before each cycle of treatment(each cycle is 21 days, for a total of 6 cycles.). During follow-up period after treatment, questionnaire every 6 months, up to 2 years.
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