Trial of Neoadjuvant Chemotherapy With S1 Plus Paclitaxel-albumin on Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03585062|
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : August 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Neoadjuvant Chemotherapy||Drug: S1, Drug: Paclitaxel-albumin||Phase 2|
- 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.
- Studies have shown that neoadjuvant therapy improves the quality of surgery in patients with pancreatic cancer，and prolong their life.
- 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.
S-1 combined with Paclitaxel-albumin
- 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.
- Paclitaxel-albumin: 125 mg/m2, intravenous infusion for 30 minutes, Day1 and Day 8.
Repeat every three weeks. for 6 cycles.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Neoadjuvant Chemotherapy With S1 Plus Paclitaxel-albumin in Patients With Unresectable Locally Advanced Pancreatic Cancer|
|Actual Study Start Date :||November 20, 2017|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: 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.
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
Other Name: Gimeracil and Oteracil Porassium Capsules
Paclitaxel-albumin is a drug which showed a survival benefit in Pancreatic Cancer when combined with S1
- R0 resection rate [ Time Frame: one week After the operation ]Evaluate the R0 resection rate of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
- The objective remission rate (ORR) [ Time Frame: at the end of cycle 6 of the neoadjuvant chemotherapy((each cycle is 21 days) ]Evaluate the objective remission rate (ORR) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
- The disease free survival (DFS) [ 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. ]Evaluate the disease free survival (DFS) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
- The 2 year and 5 year survival rate [ Time Frame: 2 years and 5 years after treatment ]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
- The quality of life [ 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. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585062
|Contact: Liu Yang, Doctoremail@example.com|
|Zhejiang procincial people's hospital||Recruiting|
|Hanzhou, Zhejiang, China, 310014|
|Contact: Liu Yang 13666601475 firstname.lastname@example.org|