Clinical Trial

A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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. This study 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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-08-24; most recent amendment 2026-07-01.
Status change: Recruiting → Active, Not Recruiting 2024-09-26
Status change: Not Yet Recruiting → Recruiting 2022-03-15
Trial Details
NCT Number NCT05026905
Lead Sponsor National Health Research Institutes, Taiwan
Collaborators: China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Taichung Veterans General Hospital
Conditions Phase II, Open-label, Parallel 2-arm, Multi-center
Enrollment 66 participants
Start Date 2021-12-28
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-02