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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

December 28, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Phase II, Open-label, Parallel 2-arm, Multi-center
Interventions
DRUG

Gemcitabine 1000 mg

Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days.

DRUG

Nab paclitaxel

Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine

DRUG

S1

"S-1 orally 60-100 mg/day day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows:~* BSA \< 1.25 m2: 60 mg/day~* 1.25 m2 ≤ BSA \< 1.5 m2: 80 mg/day~* BSA ≥ 1.5 m2: 100 mg/day"

DRUG

leucovorin

leucovorin 30mg BID day 1 to 7 on in a 2-week cycle

DRUG

Oxaliplatin

Oxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days

Trial Locations (4)

400

China Medical University Hospital, Taichung

600

National Cheng Kung University Hospital, Tainan City

800

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

Unknown

Taichung Veterans General Hospital, Taichung

All Listed Sponsors
collaborator

China Medical University Hospital

OTHER

collaborator

National Cheng-Kung University Hospital

OTHER

collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

collaborator

Taichung Veterans General Hospital

OTHER

lead

National Health Research Institutes, Taiwan

OTHER