NCT03850769

Neoadjuvant Nab-Paclitaxel and S-1 in Borderline Resectable Pancreatic Cancer

Prospective Phase II Single-arm Study of Neoadjuvant Nab-Paclitaxel and S-1 in Patients With Borderline Resectable 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 was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline resectable pancreatic cancer. A total of 60 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1, for a maximum of 4 cycles prior to pancreatectomy. The primary endpoint is R0 resection rate, the secondary endpoints include overall survival and response rate.

Conditions

• Borderline Resectable 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 \< 1.50 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14;

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-03-01
• Completion: 2022-04-01
• First posted: 2019-02-22
• Last updated: 2020-03-10

Locations

1 site across 1 country: China