drugset / Trial / NCT05959356
Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary aim of phase II CEIL study is to evaluate the efficacy of cetuximab and envafolimab plus mFOLFOXIRI versus cetuximab plus mFOLFOX6 as first line treatment of patients with initially unresectable and previously untreated RAS/BRAF wild-type, MSS, left-side metastatic colorectal cancer(mCRC), in terms of Progression-free Survival.
Timeline
- Start
- 2023-11-09
- Primary completion
- 2026-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Envafolimab | Monoclonal antibody | 200 mg | — |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | — |
| Comparator | Cetuximab | Monoclonal antibody | 500 mg/m2 | — |
| Comparator | Leucovorin | Small molecule | 200 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |