drugset / Trial / NCT03636308
Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.
Timeline
- Start
- 2018-07-17
- Primary completion
- 2020-08-01
- Completion
- 2021-08-01
Publications
- Jin M, Liu HL, Xue J, Ma H, Liu JL, Lin ZY, Wang J, Bao LQ, Luo ZG, Yu XJ, Li S, Hu JL, Zhang T. Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer: a multicenter, randomized, phase II study. Oncologist. 2024 Oct 3;29(10):e1406-e1418. doi: 10.1093/oncolo/oyae171.
- Zong Y, Yuan J, Peng Z, Lu M, Wang X, Shen L, Zhou J. Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma: a randomized study. J Cancer Res Clin Oncol. 2021 May;147(5):1529-1536. doi: 10.1007/s00432-020-03442-0. Epub 2020 Nov 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 40 mg | Oral |
| Subject | S-1 | Small molecule | 50 mg | Oral |
| Subject | S-1 | Small molecule | 60 mg | Oral |