drugset / Trial / NCT05026905
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
Phase 2
Active not recruiting
66 enrolled
National Health Research Institutes, Taiwan
China Medical University Hospital · collabKaohsiung Medical University Chung-Ho Memorial Hospital · collabNational Cheng-Kung University Hospital · collabTaichung Veterans General Hospital · collab
RandomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2021-12-28
- Primary completion
- 2027-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 30 mg | — |
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 75 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 60 mg | Oral |
| Subject | S-1 | Small molecule | 80 mg | Oral |
| Subject | S-1 | Small molecule | 100 mg | Oral |
Indications
No indication recorded.