OncoMatch/Clinical Trials/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
Is NCT06949982 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including experimental group x-MAP and Regorafenib (BAY 73-4506) for metastatic colorectal cancer (mcrc).
Treatment: experimental group x-MAP · Regorafenib (BAY 73-4506) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS mutation
Required: NRAS mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic chemotherapy — metastatic
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.
Must have received: platinum-based chemotherapy (oxaliplatin)
Patient has previously received oxaliplatin- and irinotecan-containing regimens and developed resistance to these chemotherapeutic agents.
Must have received: topoisomerase inhibitor (irinotecan)
Patient has previously received oxaliplatin- and irinotecan-containing regimens and developed resistance to these chemotherapeutic agents.
Must have received: antiangiogenic agent
systemic chemotherapy in combination with antiangiogenic agents
Cannot have received: anti-cancer systemic therapy
Any anti-cancer systemic therapy
Cannot have received: radiation therapy
radiation therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) <1.5×10^9/L, platelet count <100×10^9/L, or hemoglobin <9.0 g/dL
Kidney function
Serum creatinine >1.5 × ULN
Liver function
Serum total bilirubin >1.5 × ULN; ALT or AST >3 × ULN; Participants with Gilbert syndrome, bilirubin <2 X ULN, and normal AST/ALT are eligible
Cardiac function
Presence of clinically significant cardiovascular disease: severe or unstable ischemic heart disease, history of myocardial infarction, NYHA Class III/IV congestive heart failure, ventricular arrhythmias; stroke and/or transient ischemic attack within 6 months prior to screening; uncontrolled hypertension
Presence of clinically significant cardiovascular disease...; stroke and/or transient ischemic attack within 6 months prior to screening; uncontrolled hypertension; Absolute neutrophil count (ANC) <1.5×10^9/L, platelet count <100×10^9/L, or hemoglobin <9.0 g/dL; Serum total bilirubin >1.5 × ULN; ALT or AST >3 × ULN; Serum creatinine >1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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