NCT03779464

Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer

Detailed description

A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.

Conditions

• Pancreatic Cancer
• Nab-paclitaxel
• Gemcitabine
• S1

Interventions

Type	Name	Description
DRUG	S1 or Gemcitabine	Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area \< 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area \>1.5 m²; D1-14, q3w)

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-12-30
• Completion: 2021-09-30
• First posted: 2018-12-19
• Last updated: 2019-07-08

Locations

1 site across 1 country: China