Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. However, the nephrotoxicity of cisplatin is always a concern therefore cisplatin was substituted with oxaliplatin in current study. S-1 monotherapy has shown promising anti-tumor activity against PDAC with a manageable safety profile which provided the opportunity of combination with other agents. In this study, we will evaluate the efficacy and safety of gemcitabine, nab-paclitaxel plus S-1/LV (GASL) against gemcitabine, nab-paclitaxel plus oxaliplatin (GAP) in patients with mPDAC.
|Condition||Phase II, Open-label, Parallel 2-arm, Multi-center|
|Treatment||Oxaliplatin, Leucovorin, S1, Gemcitabine 1000 mg, nab paclitaxel|
|Clinical Study Identifier||NCT05026905|
|Sponsor||National Health Research Institutes, Taiwan|
|Last Modified on||30 June 2022|
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