NCT05818267

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

Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC) Without Imaging Progress Three Months After Second-Line Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Wei Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Regorafenib in third-line treatment of metastatic colorectal cancer(mCRC) significantly prolongs the survival of patients, and its advancement has a sensitizing effect on postline chemotherapy and thus improves the prognosis of patients. Therefore, the present study was designed to include patients who achieved stable disease/partial response(SD/PR) after 3 months of second-line therapy and advance regorafenib to investigate the role of advance regorafenib in prolonging progression-free survival, prolonging the efficacy of overall survival, safety, and quality of life in patients with mCRC compared with standard second-line and third-line therapy.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-26
• Primary completion: 2025-03-01
• Completion: 2025-11-01
• First posted: 2023-04-18
• Last updated: 2023-07-14

Locations

1 site across 1 country: China