This trial is a single center observational real-world study. It is planned to include 300 patients with unresectable hepatocellular carcinoma (uHCC) treated with Donafenib. The purpose of the study was to observe the effectiveness and safety of Donafenib in the real world.
Study Type
OBSERVATIONAL
Enrollment
300
Zhongshan Hospital, Fudan University,
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of adverse events and serious adverse events.
Incidence of adverse events and serious adverse events.
Time frame: an average of 1.5 year.
Objective response rate (ORR)
According to RECIST v1.1 and mRECIST to evaluate the proportion of patients with complete response(CR) and partial response(PR) in the total number of patients.
Time frame: an average of 1 year.
Duration of remission (DoR)
Time from the date of first confirmed CR or PR to the occurrence of disease progression.
Time frame: an average of 1 year.
Disease control rate (DCR)
According to RECIST v1.1 and mRECIST to evaluate the proportion of patients with CR, PR and stable disease(SD) in the total number of patients.
Time frame: an average of 1 year
Progression-free survival(PFS)
PFS refers to the time from the date of enrollment to tumor progression or death from any cause.
Time frame: an average of 1 year
overall survival(OS)
The time from the date of enrollment to the date of death from any cause.
Time frame: an average of 1 year
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