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

NCT05026905 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	National Health Research Institutes, Taiwan
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	66
Start date	2021-12-28
Completion	2027-12

Conditions

• Phase II, Open-label, Parallel 2-arm, Multi-center

Interventions

• Gemcitabine 1000 mg
• Nab paclitaxel
• S1
• leucovorin
• Oxaliplatin

Primary outcomes

• Best objective response rate (ORR) — 6 years
  tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

Countries

Taiwan