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

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.

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

Sponsors & Collaborators

• China Medical University Hospital

  collaborator OTHER

• National Cheng-Kung University Hospital

  collaborator OTHER

• Kaohsiung Medical University Chung-Ho Memorial Hospital

  collaborator OTHER

• Taichung Veterans General Hospital

  collaborator OTHER

• National Health Research Institutes, Taiwan

  lead OTHER

Principal Investigators

• Li-Tzong Chen, MD, Ph.D. · National Health Research Institutes, Taiwan

• Yung-Yeh Su, M.D. · National Health Research Institutes, Taiwan

• Shang-Hung Chen, M.D. · National Health Research Institutes, Taiwan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-28

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Taiwan

Study Locations