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Brief Title: Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer
Official Title: Phase II Trial Comparing Nab-paclitaxel Plus S-1 Versus Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Patients With Advanced Pancreatic Cancer
Study ID: NCT03636308
Brief Summary: This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.
Detailed Description: Advanced pancreatic ductal adenocarcinoma (PDAC) is an aggressive and chemo-resistant disease with extremely low 5-year survival rate. Gemcitabine has been the cornerstone of metastatic PDAC treatment for more than a decade , although survival benefit was very poor. Nab-paclitaxel added to gemcitabine has showed improving survival and overall response rate vs gemcitabine alone in metastatic PDAC first-line treatment in the MPACT phaseIII study, which represents one of the standards of care in advanced PDAC therapy. S-1 is an oral 5-fluorouracil (5-FU) prodrug, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer. Meanwhile, adjuvant chemotherapy with S-1 monotherapy was found to significant prolong survival of pancreatic cancer patients when compared with gemcitabine. This study is to explore the efficacy and safety of nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) as first-line treatment in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Peking University Cancer Hospital and Institute, Beijing, Beijing, China
Name: Lin Shen, Professor
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR