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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGduration of disease control(DDC)
From second-line treatment initiation to third disease progression
Time frame: 6 month
Overall Survival(OS)
Subjects were censored from the time of enrollment to the time of death from any cause, and the date of censoring was the date of the last follow-up visit if the subject's last status was alive.
Time frame: 3 years
Quality-of-Life(QoL)
Quality-of-life was evaluated using the Quality-of-Life Questionnaire C30 (EORTC QLQ-C 30) developed by the European organization for research and treatment of cancer (EORTC)
Time frame: 3 years
The incidence of adverse events
Adverse Events (AE) will be evaluated and graded according to NCI-CTCAE v5.0. All adverse events will be reported at length.
Time frame: 3 years
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