drugset / Trial / NCT04683965
Pemetrexed and TAS-102 in Combination With Bevacizumab in Refractory Colorectal Cancer
Phase 2
Unknown
27 enrolled
The First Affiliated Hospital with Nanjing Medical University
Jiangsu Hansoh Pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
Limited agents are optional after standard first and second line treatment for mCRC. Only Regorafenib and Fruquintinib are approved in China. PFS of these targeted drugs are not very long. Pemetrexed has shown significant efficacy in advanced lung cancer regarding PFS and OS with controllable toxicity. TAS-102 has been used in colorectal cancer with promising outcomes. Bevacizumab is also an important monoclonal antibody which could make benefits in treated patients. This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.
Timeline
- Start
- 2021-01-01
- Primary completion
- 2024-01-01
- Completion
- 2024-05-01
Publications
- Background Wu XY, Huang XE, You SX, Lu YY, Cao J, Liu J. Phase II study of pemetrexed as second or third line combined chemotherapy in patients with colorectal cancer. Asian Pac J Cancer Prev. 2013;14(3):2019-22. doi: 10.7314/apjcp.2013.14.3.2019.
- Background Passardi A, Fanini F, Turci L, Foca F, Rosetti P, Ruscelli S, Casadei Gardini A, Valgiusti M, Dazzi C, Marangolo M. Prolonged Pemetrexed Infusion Plus Gemcitabine in Refractory Metastatic Colorectal Cancer: Preclinical Rationale and Phase II Study Results. Oncologist. 2017 Aug;22(8):886-e79. doi: 10.1634/theoncologist.2017-0206. Epub 2017 Jun 7.
- Background Lim SW, Lee S, Lee J, Park SH, Park JO, Park YS, Lim HY, Kang WK, Kim ST. Pemetrexed Monotherapy as Salvage Treatment in Patients with Metastatic Colorectal Cancer Refractory to Standard Chemotherapy: A Phase II Single-arm Prospective Trial. J Cancer. 2018 Jul 30;9(16):2910-2915. doi: 10.7150/jca.24948. eCollection 2018.
- Background Yu Z, Wang J, Cai X, Gao Z, Wang S, Gu Y. Analysis of pemetrexed-based chemotherapy in the treatment of advanced colorectal cancer. Ann Transl Med. 2020 Nov;8(21):1368. doi: 10.21037/atm-20-1095.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | — |
| Subject | TAS-102 | Small molecule | 35 mg/m2 | Oral |