TACE (transarterial chemoembolization)
ProcedureFirst treatment for all patients included in the study
NCT Number: NCT01933945
This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.
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Observational
Multiple Locations, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
First treatment for all patients included in the study
Time frame: Up to 3 years
Defined as time (in days) from time of TACE non-eligibility to death due to any cause. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.
Time frame: Up to 3 years
OS from initial TACE was defined as the time interval from the day of the first TACE to death due to any cause.
Time frame: Up to 3 years
PFS from initial TACE was defined as the time interval measured from the day of the first TACE to documented (radiological or clinical) progression or death, whichever came first.
Time frame: Up to 3 years
TTP from initial TACE was defined as the time interval from the day of first TACE to the date of documented progression.
Time frame: Up to 3 years
Tumor response to TACE by modified Response Evaluation Criteria In Solid Tumors (mRECIST) were evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", and "Not evaluable" by mRECIST for each TACE.
Time frame: Up to 3 years
Duration of TACE treatment was defined as the time interval from of the day of first TACE to the date of permanent discontinuation of TACE
Time frame: Up to 3 years
Patients were monitored for TEAEs using the NCI-CTCAE Version 4.03.
Time frame: Up to 3 years
TACE unsuitability was determined according to selected guidelines
Time frame: Up to 3 years
Determined according to the selected guidelines
Time frame: Up to 3 years
Deteriorations of liver dysfunction were defined as follow: Deterioration of Child Pugh score (A5, A6, B7, B8, B9); Liver dysfunction reported as AE or deterioration of aspartate aminotransferase, alanine aminotransferase or bilirubin (from Grade 1 to Grade 2-5, from Grade 2 to 3-5, Grade 3 to Grade 4 or 5); Any liver related adverse events or deterioration of liver related events according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03; Change of liver related laboratory data (aspartate aminotransferase, alanine aminotransferase, bilirubin, albumin, prothrombin international normalized ratio [INR])
Time frame: Up to 3 years
OS from initiation of sorafenib was defined as the time interval measured from start date of sorafenib treatment to death due to any cause.
Time frame: Up to 3 years
PFS from initiation of sorafenib was defined as the time interval measured from the start date of sorafenib treatment to documented (radiological or clinical) progression or death, whichever came first.
Time frame: Up to 3 years
mRECIST: modified Response Evaluation Criteria In Solid Tumors
Time frame: Up to 3 years
Duration of sorafenib treatment was defined as the time interval from start date of sorafenib treatment to the date of permanent discontinuation of sorafenib treatment (regardless of the reason for discontinuation including death).
Time frame: Up to 3 years
TTP from initiation of sorafenib was defined as the time interval from start date of sorafenib treatment to the date of documented progression.
Time frame: Up to 3 years
PFS from TACE non-eligibility was defined as the time interval from TACE non-eligibility to documented (radiological or clinical) progression or death, whichever came first.
Time frame: Up to 3 years
TTP from TACE non-eligibility was defined as the time interval from TACE non-eligibility to the date of documented progression.
Time frame: Up 3 years
Planned to be evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", and "Not evaluable"
Time frame: Up to 3 years
Evaluated according to the categories "Before initial TACE", "After one TACE", "After two TACEs", and "After more than two TACEs"
Time frame: Up to 3 years
Deviations from recommendations for TACE use in the treatment guidelines for TACE use based on the number of patients for whom the treatment decision for a new TACE was made by the investigator after TACE non-eligibility.
Time frame: Up to 3 years
Defined as days from the first sorafenib dose to the date of permanent discontinuation of sorafenib plus one
Bayer
Industry
OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib
Acronym: OPTIMIS
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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