A Randomized Trial To Compare Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Versus Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes
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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Provide written informed consent
• Age ≥ 18 years
• Histologically confirmed diagnosis of colorectal cancer (CRC) with distant metastases.
• Presence of mutations in the KRAS or NRAS gene.
• Participants must have previously treated for metastatic colorectal cancer and experienced disease progression during receiving at least 2 lines of systemic chemotherapy in combination with antiangiogenic agents.
• Patient has previously received oxaliplatin- and irinotecan-containing regimens and developed resistance to these chemotherapeutic agents.