RecruitingPhase 2NCT06949982

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

A Randomized Trial To Compare Efficacy And Safety Of Hydroxychloroquine Combined With Methotrexate, Capecitabine And Bevacizumab Versus Regorafenib In Participants With Refractory Metastatic Colorectal Cancer With Mutations In RAS Genes


Sponsor

Sergey Orlov, MD

Enrollment

60 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for people with advanced colorectal cancer that has spread and no longer responds to standard chemotherapy. One arm combines hydroxychloroquine (a drug used for autoimmune conditions) with methotrexate, capecitabine, and bevacizumab; the other uses regorafenib, a standard last-line therapy. **You may be eligible if...** - You are 18 years or older - You have metastatic colorectal cancer with a KRAS or NRAS gene mutation - Your cancer has progressed after at least 2 prior chemotherapy regimens including oxaliplatin and irinotecan - You are in relatively good health and can perform daily activities (ECOG 0-1) **You may NOT be eligible if...** - You have significant heart problems, a recent heart attack, or uncontrolled high blood pressure - You have had a recent stroke or transient ischemic attack (TIA) - You have significant kidney or liver disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTexperimental group x-MAP

hydroxychloroquine 200 mg TID PO+ methotrexate 2.5 mg BID twice a week PO+ capecitabine 1000 mg/m2 PO BID for 14 days+ bevacizumab 7.5 mg/m2 IV on day 1, every 3 weeks.

DRUGRegorafenib (BAY 73-4506)

Regorafenib 160 mg PO daily on days 1-21, every 28 days OR 1st cycle: Regorafenib 80 mg PO daily on days 1-7, followed by 120 mg PO daily on days 8-14, followed by 160 mg PO daily on days 15-21, every 28 days, 2nd and subsequent cycles: Regorafenib 160 mg PO daily on days 1-21, every 28 days


Locations(1)

First Pavlov State Medical University

Saint Petersburg, Sankt-Peterburg, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06949982


Related Trials