Evaluating Regorafenib With Metronomic Chemotherapy and Low-Dose Aspirin Versus Standard Regorafenib in Treating Chemo-Resistant Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the effect of combining Regorafenib with metronomic chemotherapy capecitabine and cyclophosphamide and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic colorectal cancer who are resistant to chemotherapy. This phase 2 randomized trial aims to assess progression-free survival as the main outcome to better understand treatment impact in this patient group. Participants are assigned to one of two groups one receives Regorafenib alone, and the other receives Regorafenib plus metronomic chemotherapy and low-dose aspirin. Regorafenib is given 3 weeks out of every 4-week cycle, starting with a stepwise dosing schedule in the first cycle and then continuing at adjusted doses based on tolerance. The combination group receives cyclophosphamide daily for 6 months, capecitabine twice daily for 6 months, and aspirin daily until disease progression. During the study, participants undergo blood sampling for plasma and circulating tumor DNA analysis, fresh tumor biopsies at baseline and week 8, and complete quality of life questionnaires at multiple times including baseline and follow-up visits. Researchers monitor safety, treatment effects, and progression-free survival over time. The total participation duration varies depending on individual disease progression and tolerance to treatments.

Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers