This Retrospective Real-world study was designed to evaluate the clinical efficacy and safety of the Combination of transarterial therapies with donafenib plus Anti-PD-1 Antibody for Unresectable Hepatocellular Carcinoma.
Data of Patients who have received Triplet therapy ( transarterial therapies+donafenib+Anti-PD-1 Antibody）will be collected，excluding incomplete data. The primary endpoint was the objective response rate (ORR)，Secondary endpoints included disease control rate (DCR), progression-free survival rate (PFSR) \[ Time Frame: 6- and 12-month\], overall survival rate (OSR) \[ Time Frame: 6- and 12-month\], the median progression-free survival time (mPFS) and median overall survival time (mOS)， as well as adverse event.
Study Type
OBSERVATIONAL
Enrollment
100
transarterial therapies combine with donafenib and Anti-PD-1 Antibody
the objective response rate (ORR)
ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST
Time frame: From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
disease control rate (DCR)
DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST
Time frame: From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
The progression-free survival rate (PFSR)
PFSR is defined as the percentage of participants who have not accured disease progression or death at the time of 6 or 12 months as assessed by RECIST 1.1 and mRECIST
Time frame: From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first (max 24 months)
The overall survival rate (OSR)
OSR is defined as the percentage of participants who still alive at the time of 6 or 12 months.
Time frame: From date of begining triplet therapy to the date of first documentation of death from any cause, whichever occurs first (max 24 months)
The progression-free survival time (mPFS)
The progression-free survival time (mPFS) defined as the time from begining triplet therapy to the date of first documentation of disease progression as assessed by RECIST 1.1 and mRECIST
Time frame: From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first(max 24 months)
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The median overall survival time (mOS)
OS is measured from the start date of the Treatment (date of begining triplet therapy) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.
Time frame: From the start date of the Treatment until date of death from any cause (max 24 months)
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From the begining triplet therapy until date of death from any cause (max 24 months)