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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).

Phase 2RecruitingSergey Orlov, MDNCT06949982Data as of May 2026

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.

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Extracted 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

Min 2 prior lines

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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