Pancreatic Cancer Research

Clinical trialPhase 2Unknown

Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer

Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer

Outcome
Outcome unknown
Phase
Phase 2
Status
Unknown
Study type
Interventional
Start
April 2014
Expected end
May 2017
Enrollment
60 participants
Sites
1
Primary outcomes
Objective response rate
Sponsor
Other
Results posted
No
Last update
22 December 2016

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Brief summary public domain (ClinicalTrials.gov)

The purpose of this study is to determine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus S-1 as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma (PDA).

Detailed description public domain (ClinicalTrials.gov)

Advanced PDA is a lethal disease with a approximately 6 months of median survival. Gemcitabine is always the only approved single agent. The recent results of the phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and overall survival (OS) for the combination of nab-paclitaxel plus gemcitabine compared to gemcitabine alone. Thus, the combination of nab-paclitaxel with gemcitabine became one of a standard treatment in metastatic PDA. S-1 is an oral fluoropyrimidine, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer, and also demonstrated non-inferior, and even superior to gemcitabine as adjuvant chemotherapy. This single-arm study is to explore the efficacy and safety of nab-paclitaxel plus S-1 as first-line treatment in Chinese patients with local advanced or metastatic pancreatic ductal adenocarcinoma.