Actively Recruiting
A Randomized Trial Comparing Hydroxychloroquine Combined With Methotrexate, Capecitabine, and Bevacizumab Versus Regorafenib in Refractory Metastatic Colorectal Cancer With RAS Gene Mutations
Led by Sergey Orlov, MD · Updated on 2025-05-04
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
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 mg/m2 twice daily for 14 days, and bevacizumab 7.5 mg/m2 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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Provide written informed consent
- Age 18 years or older
- Histologically confirmed colorectal cancer with distant metastases
- Presence of mutations in the KRAS or NRAS gene
- Previously treated metastatic colorectal cancer with progression after at least 2 lines of systemic chemotherapy combined with antiangiogenic agents
- Prior treatment with oxaliplatin- and irinotecan-containing regimens and development of resistance to these agents
You will not qualify if you...
- Clinically significant cardiovascular disease such as severe or unstable ischemic heart disease, recent myocardial infarction, severe congestive heart failure, or ventricular arrhythmias
- Stroke or transient ischemic attack within 6 months prior to screening
- Uncontrolled hypertension
- History of previous malignancies except certain skin, cervical, or breast cancers with remission of at least 2 years and no ongoing therapy
- Patients with central nervous system metastases unless adequately treated
- Low blood counts including low neutrophils, platelets, or hemoglobin
- Elevated liver enzymes or bilirubin beyond specified limits
- Elevated serum creatinine above specified limits
- History of thromboembolic events
- Allergic reactions to study drug components
- Use of medications known to cause QT prolongation or Torsades de Pointes
- Any ongoing anti-cancer systemic or radiation therapy
- Pregnant or lactating women
- Unresolved moderate or higher toxicity from prior therapy except specified conditions
- Any serious or uncontrolled medical condition, infection, or psychiatric disorder that could increase risk or affect compliance
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until disease progression or unacceptable toxicity
Participants receive assigned systemic therapy: either the x-MAP regimen (hydroxychloroquine, methotrexate, capecitabine, and bevacizumab) or regorafenib treatment until disease progression or unacceptable toxicity.
Regular visits for treatment administration and monitoring according to local standards
Duration - Up to approximately 38 months from start of study drug administration
Participants are monitored for overall survival, disease control, response duration, and treatment-emergent adverse events after treatment ends.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
First Pavlov State Medical University
Saint Petersburg, Sankt-Peterburg, Russia, 197022
Actively Recruiting
Research Team
S
Sergey V. Orlov, Professor
A
Aram A. Musaelyan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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