NCT03885219

Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer

Prospective Phase II Single-arm Study of Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, multi-center, open-label prospective phase II clinical study designed to evaluate the efficacy and safety of nab-paclitaxel and S-1 in patients with locally advanced pancreatic cancer. A total of 60 subjects who meet the criteria will be treated with nab-paclitaxel and S-1. The primary endpoint is 6 months progression free survival rate, and secondary endpoints include objective response rate, overall survival, progression free survival and toxicities.

Conditions

• Locally Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel and S-1	Nab-paclitaxel: 120 mg/m2 d1, 8, S-1:Body surface area \< 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 , \< 1.5 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14; repeat every 21 days.

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-03-01
• Completion: 2022-04-01
• First posted: 2019-03-21
• Last updated: 2020-03-10

Locations

1 site across 1 country: China