Actively Recruiting
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
Led by Sergey Orlov, MD · Updated on 2025-05-04
60
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 for metastatic colorectal cancer with disease progression after at least 2 lines of systemic chemotherapy combined with antiangiogenic agents
- Prior treatment with oxaliplatin- and irinotecan-containing regimens and developed resistance to these chemotherapies
You will not qualify if you...
- Severe or unstable ischemic heart disease, history of myocardial infarction, New York Heart Association Class III/IV heart failure, or ventricular arrhythmias
- Stroke or transient ischemic attack within 6 months before screening
- Uncontrolled hypertension
- History of previous cancers except non-melanoma skin cancer or certain treated cancers unless in complete remission for at least 2 years with no ongoing therapy
- Patients with central nervous system metastases unless adequately treated
- Low blood counts: absolute neutrophil count below 1.5 x 10^9/L, platelet count below 100 x 10^9/L, or hemoglobin below 9.0 g/dL
- Serum total bilirubin above 1.5 times the upper limit of normal except for Gilbert syndrome with normal liver enzymes
- Alanine aminotransferase or aspartate aminotransferase above 3 times the upper limit of normal
- Serum creatinine above 1.5 times the upper limit of normal
- History of thromboembolic events
- Allergy to any study drug components
- Use of medications known to cause QT prolongation or Torsades de Pointes
- Any anti-cancer systemic therapy or radiation therapy ongoing
- Women who are pregnant or breastfeeding
- Unresolved adverse events of grade 2 or higher from prior therapy except mild alopecia or neurotoxicity
- Any serious or uncontrolled medical condition, active infection, mental health condition, or other factors that could interfere with study participation or safety
AI-Screening
AI-Powered Screening
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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
CONTACT
A
Aram A. Musaelyan, PhD
CONTACT
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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