This study is to obtain the characteristics and treatment pattern of the unresectable HCC patients who are candidates for systemic therapy and in whom a decision to treat with sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd TACE procedure) has been made under real-life practice conditions.this study will also conclude the safety and effectiveness of combination in uHCC patients.
Study Type
OBSERVATIONAL
Enrollment
302
sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator
Unnamed facility
Multiple Locations, China
Summarized patient characteristics
Patient characteristics are hepatic virus infection status, surgery history, tumor size, number of tumor, macroscopic vascular invasion (MVI), extra-hepatic spread (EHS), cirrhosis, ECOG score, Child-Pugh score, BCLC stage, etc.
Time frame: up to 3 years
Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability
Time frame: up to 3 years
overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients
Time frame: up to 3 years
progression-free survival (PFS) by the mRECIST for treatment of uHCC patients
Time frame: up to 3 years
time to progression (TTP) by the mRECIST for treatment of uHCC patients
Time frame: up to 3 years
response rate (RR) by the mRECIST for treatment of uHCC patients
Time frame: up to 3 years
Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients
Time frame: up to 3 years
Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients
Time frame: up to 3 years
Treatment pattern of Sorafenib
Treatment pattern included: Duration and dosage of Sorafenib treatment; reason for Sorafenib dosage modification/discontinuation; anticancer combination therapy; treatment after radiographic relapse; comorbidities and their impact on disease outcome.
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Time frame: up to 3 years