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.
Papers 1
- Registry-listed results paperNab-paclitaxel plus S-1 in advanced pancreatic adenocarcinoma (NPSPAC): a single arm, single center, phase II trial. DOI 10.18632/oncotarget.21359↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.