This study is a prospective, single-center, observational real-world study. It is planned to enroll 150 patients with unresectable hepatocellular carcinoma treated with Donafenib combined with TACE-based treatment, so as to observe and evaluate the efficacy and safety of Donafenib combined with TACE-based treatment in patients with unresectable HCC.
Study Type
OBSERVATIONAL
Enrollment
150
Donafenib(200mg bid po) combined with TACE
Fudan University
Shanghai, China
RECRUITINGProgression Free Survival
Defined as the time from the start of enrollment to the occurrence of disease progression that cannot be treated by TACE or death due to various reasons.
Time frame: an expected average of 8 months
Objective response rate
evaluated by investigators with mRECIST
Time frame: an expected average of 12 months
Disease control rate
evaluated by investigators with mRECIST
Time frame: an expected average of 12 months
Time to untreatable progression
It is defined as the time when a tumor that cannot be treated by TACE progresses, deteriorates to Child-pugh C, or appears extrahepatic metastasis.
Time frame: an expected average of 12 months
Overall survival
The time from enrollment to the death from any cause
Time frame: an expected average of 18 months
The incidence of AEs and SAEs by NCI-CTCAE v5.0
Safety index
Time frame: an expected average of 18 months
Conversion rate
Defined as the proportion of patients who can undergo radical surgical resection through conversion therapy.
Time frame: an expected average of 18 months
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