Trial Condition(s):
Carcinoma, Hepatocellular
Sorafenib concomitantly used with TACE (Transarterial Chemoembolization) in uHCC (unresectable hepatocellular carcinoma) patients in China (SUCCESS)
Bayer Identifier:
16608
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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 - Exclusion criteria must follow the approved local product information
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, China | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
Study on Transarterial chemoembolization combined with Sorafenib in Chinese patients with unresectable hepatocellular carcinoma (SUCCESS)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Summarized patient characteristicsPatient 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.Timeframe: up to 3 years
Secondary Outcome
- Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorabilityTimeframe: up to 3 years
- overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patientsTimeframe: up to 3 years
- progression-free survival (PFS) by the mRECIST for treatment of uHCC patientsTimeframe: up to 3 years
- time to progression (TTP) by the mRECIST for treatment of uHCC patientsTimeframe: up to 3 years
- response rate (RR) by the mRECIST for treatment of uHCC patientsTimeframe: up to 3 years
- Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patientsTimeframe: up to 3 years
- Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patientsTimeframe: up to 3 years
- Treatment pattern of SorafenibTreatment 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.Timeframe: up to 3 years
Additional Information
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