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

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 17, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

October 31, 2027

Conditions
Metastatic Colorectal Cancer (mCRC)Colorectal Neoplasms
Interventions
COMBINATION_PRODUCT

experimental 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.

DRUG

Regorafenib (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

Trial Locations (1)

197022

RECRUITING

First Pavlov State Medical University, Saint Petersburg

All Listed Sponsors
lead

Sergey Orlov, MD

OTHER