Comparing Hydroxychloroquine with Methotrexate, Capecitabine, and Bevacizumab Versus Regorafenib for Advanced Colorectal Cancer with RAS Gene Mutations

What this Trial Is About

This research aims to assess the effectiveness and safety of a combination treatment including hydroxychloroquine, methotrexate, capecitabine, and bevacizumab compared to regorafenib in adults with refractory metastatic colorectal cancer that have mutations in the KRAS or NRAS genes. The study focuses on patients who have already undergone standard chemotherapy treatments but whose cancer has progressed. It explores whether the combination can improve progression-free survival, overall survival, and response rates. Participants will be randomly assigned to receive either the combination regimen hydroxychloroquine 200 mg three times daily, methotrexate 2.5 mg twice weekly, capecitabine 1000 mgm2 twice daily for 14 days, and bevacizumab 7.5 mgm2 intravenously every three weeks until disease progression or unacceptable side effects occur, or regorafenib following local standard dosing schedules. Regorafenib dosing may start at lower doses escalating to 160 mg daily on a 21-day cycle every 28 days. During the trial, participants will undergo regular evaluations to assess tumor response using RECIST 1.1 criteria, measuring objective response rate and progression-free survival up to 24 months. Researchers will also monitor overall survival, disease control, duration of response, and treatment-emergent adverse events for up to about 38 months. The study includes ongoing safety monitoring and requires participants to provide informed consent and meet specific health and laboratory criteria.

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