Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC)

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 26, 2023

Primary Completion Date

March 31, 2025

Study Completion Date

November 30, 2025

Conditions
Colorectal Cancer
Interventions
DRUG

Regorafenib

The drug dose that taken by the subject is gradually increased to the maximum dose tolerated by the patient according to individualization. Specifically, the initial dose of 80 mg/day was gradually increased to 120 mg/day (80 mg/day in the first week, 120 mg/day in the second week, and a maximum tolerated dose of 160 mg/day). The maximum tolerated dose is 160 mg/day. The dose is administered once daily in a 4-week cycle (3 weeks of dosing and 1 week of rest) and the maximum dose achieved in the first treatment cycle is maintained.At the discretion of the investigator, regorafenib may be delayed or discontinued. Dose adjustments and interruptions due to toxicity are made according to the recommendations specified in the protocol.

Trial Locations (1)

200433

RECRUITING

Department of Colorectal Surgery in Changhai Hospital, Shanghai

All Listed Sponsors
lead

Wei Zhang

OTHER