Multiple Locations, China
NCT Number: NCT01839630
Sorafenib Concomitantly Used With TACE (Transarterial Chemoembolization) in uHCC (Unresectable Hepatocellular Carcinoma) Patients in China
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.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sorafenib (Nexavar, BAY43-9006)
Drugsorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator
Primary outcomes
-
Summarized patient characteristics
Time frame: 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 outcomes
-
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
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Bayer
Industry
Registry information
Official study title
Study on Transarterial Chemoembolization Combined With Sorafenib in Chinese Patients With Unresectable Hepatocellular Carcinoma (SUCCESS)
Acronym: SUCCESS
Important dates
- Study start
- 2013
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Apr 25, 2013
- Registry last updated
- Dec 20, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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