drugset / Trial / NCT04136600
EGFR Monoclonal Antibody for Advanced Gastric Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is intended to evaluate efficacy and safety of EGFR monoclonal antibody (Cetuximab/Nimotuzumab) in combination with a chemotherapy in gastric cancer patients with EGFR amplification.
Timeline
- Start
- 2019-07-01
- Primary completion
- 2021-08-31
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Nimotuzumab | Monoclonal antibody | 400 mg | Intravenous |
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Comparator | S-1 | Small molecule | 40 mg | Oral |
| Comparator | S-1 | Small molecule | 50 mg | Oral |
| Comparator | S-1 | Small molecule | 60 mg | Oral |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |