drugset / Trial / NCT05945901
A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a double-blind, randomized, multi-center, II/III study in at least 606 patients with advanced colorectal cancer. The study is being conducted to evaluate the safety of HR070803 combined with oxaliplatin, 5-FU/LV and bevacizumab in phase II and to evaluate the efficacy of HR070803 in combination with oxaliplatin, 5-FU/LV, and bevacizumab versus HR070803 simulator in combination with FOLFOX and bevacizumab for first-line treatment of patients with unresectable metastatic colorectal cancer.
Timeline
- Start
- 2023-08-14
- Primary completion
- 2025-12-01
- Completion
- 2026-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HR070803 | Unknown | — | — |
| Comparator | Bevacizumab | Monoclonal antibody | — | — |
| Background | LV | Unknown | — | — |
| Comparator | LV | Unknown | — | — |
| Comparator | Oxaliplatin | Small molecule | — | — |
| Comparator | fluorouracil | Small molecule | — | — |