drugset / Trial / NCT06949982
Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Vs. Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate efficacy and safety of hydroxychloroquine combined with methotrexate, capecitabine and bevacizumab versus regorafenib in participants with refractory metastatic colorectal cancer with mutations in KRAS or NRAS genes. The hypotheses of this study are that a combination of hydroxychloroquine, methotrexate, capecitabine, and bevacizumab (compared to regorafenib) prolongs progression-free survival and overall survival, and also increases rates of objective responses and disease control.
Timeline
- Start
- 2025-03-17
- Primary completion
- 2027-04
- Completion
- 2027-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/m2 | Intravenous |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Hydroxychloroquine | Small molecule | 200 mg | Oral |
| Subject | Methotrexate | Small molecule | 2.5 mg | Oral |
| Comparator | Regorafenib | Small molecule | 160 mg | Oral |