drugset / Trial / NCT05074966
The Efficacy and Safety of Modified XELOX(mXELOX) Plus Cetuximab vs FOLFOX Plus Cetuximab in RAS and BRAF WT mCRC Pts
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open label, multicenter, randomized study in Chinese patients with RAS and BRAF wild-type mCRC. Participants were randomly assigned to cetuximab + FOLFOX (group A) and cetuximab + modified XELOX\[mXELOX\] (group B). All patients in groups A and B will be treated until progression of disease(PD), death, intolerable toxicity or withdrawal of informed consent, whichever occurs first.
Timeline
- Start
- 2021-09-06
- Primary completion
- 2024-06-24
- Completion
- 2025-06-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 850 mg/m2 | Oral |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 1200 mg/m2 | Intravenous |
| Background | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |