Neoadjuvant Nab-Paclitaxel and S-1 in Resectable Pancreatic Cancer
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.
Timeline
- Start
- 2021-03
- Primary completion
- 2023-02
- Completion
- 2024-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | — |
| Subject | S-1 | Small molecule | 40 mg | — |
| Subject | S-1 | Small molecule | 50 mg | — |
| Subject | S-1 | Small molecule | 60 mg | — |