NCT04808687

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

Phase II Single-arm Trial of Nab-Paclitaxel and S-1 as Neoadjuvant Treatment of Patients With Resectable Pancreatic Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

There were limited data for nab-paclitaxel and S-1 in pancreatic cancer. To explore the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with resectable pancreatic cancer (stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions ), we designed this study. This study was a single-arm single center prospective phase II clinical study. A total of 72 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1 prior to pancreatectomy. Response was reported according to the Response Evaluation Criteria in Solid Tumors guidelines (RECIST, version 1.1) .The primary endpoint is objective response rate. The secondary endpoints include R0/R1 resection rate, disease free survival, overall survival and safety.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	Nab paclitaxel and S-1	Nab-Paclitaxel: 125 mg/m2 d1, 8, during each 3-week cycle. S-1: Body surface area \< 1.25 m2, 40 mg bid; Body surface area ≥ 1.25 m2 \< 1.50 m2, 50 mg bid; Body surface area ≥1.5 m2, 60 mg bid, d1-14;during each 3-week cycle.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-02-01
• Completion: 2024-02-01
• First posted: 2021-03-22
• Last updated: 2021-03-22

Locations

1 site across 1 country: China