Carcinoma, Hepatocellular
Conditions
Keywords
Sorafenib, Hepatocellular cancer, TACE combination, Treatment pattern, Safety, Effectiveness
Brief summary
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.
Interventions
DRUGSorafenib (Nexavar, BAY43-9006)
sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator
Sponsors
Bayer
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with histologically/ cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI; * Patients receive the first dose of sorafenib no later than 1 week (\<=7days) after the 3rd TACE procedure * Patients did not receive other prior systemic treatment by using target therapy * Patients must sign the informed consent form; * Patients must have a life expectancy of at least 3 months; * The physician must be willing to complete and submit all CRFs; * The physician must be willing to submit to a site audit with verification of source documents and validation of data reported;
Exclusion criteria
* The first dose of sorafenib 7 days after the 3nd TACE procedure *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summarized patient characteristics | up to 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients | up to 3 years | — |
| progression-free survival (PFS) by the mRECIST for treatment of uHCC patients | up to 3 years | — |
| time to progression (TTP) by the mRECIST for treatment of uHCC patients | up to 3 years | — |
| Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability | up to 3 years | — |
| Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients | up to 3 years | — |
| Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients | up to 3 years | — |
| Treatment pattern of Sorafenib | up to 3 years | 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. |
| response rate (RR) by the mRECIST for treatment of uHCC patients | up to 3 years | — |
Countries
China
Outcome results
None listed