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| ID | Type | Description | Link |
|---|---|---|---|
| NX1301 | Other Identifier | Company internal |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE + early Nexavar | Patients with early start of Sorafenib treatment. This cohort comprises all patients where the physician decides at the time of TACE non-eligibility to choose Sorafenib as the next treatment option (regardless of whether TACE treatment is continued or not). |
| |
| TACE without early Nexavar | Patients without early start of Sorafenib treatment. This cohort comprises all patients where the physician decides at the time of TACE non-eligibility not to choose Sorafenib as the next treatment option. This cohort also includes patients with TACE non-eligibility for whom the decision to treat with Sorafenib is made at a later point in time, patients who are never treated with Sorafenib as well as patients for whom another systemic cancer treatment has been chosen be the physician either at time of TACE non-eligibility or at a later point in time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE (transarterial chemoembolization) | Procedure | First treatment for all patients included in the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 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. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival from initial TACE | OS from initial TACE was defined as the time interval from the day of the first TACE to death due to any cause. | Up to 3 years |
| Progression-free survival (PFS) from initial TACE |
| Measure | Description | Time Frame |
|---|---|---|
| PFS from TACE non-eligibility | 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. | Up to 3 years |
| TTP from TACE non-eligibility |
Inclusion Criteria:
Exclusion Criteria:
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Female and male patients with a diagnosis of hepatocellular carcinoma (HCC) will be enrolled in the participating study countries and sites during the enrollment period. All treatment decisions prior inclusion of a patient as well as during the observation must be made by the investigator based on his regular medical practice. Patients must give written informed consent prior to documentation.
During the course of the study, patients will be assigned to one of the following cohorts of special interest:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Austria | |||||
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| Sorafenib (Nexavar, BAY43-9006) | Drug |
|
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.
| Up to 3 years |
| Time to progression (TTP) from initial TACE | TTP from initial TACE was defined as the time interval from the day of first TACE to the date of documented progression. | Up to 3 years |
| Tumor response according to mRECIST criteria | 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. | Up to 3 years |
| Duration of TACE treatment | 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 | Up to 3 years |
| Number of patients with TEAEs (treatment emergent adverse events) | Patients were monitored for TEAEs using the NCI-CTCAE Version 4.03. | Up to 3 years |
| TACE unsuitability | TACE unsuitability was determined according to selected guidelines | Up to 3 years |
| Time to TACE non-eligibility | Determined according to the selected guidelines | Up to 3 years |
| Deterioration of liver dysfunction | 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]) | Up to 3 years |
| OS from initiation of sorafenib | OS from initiation of sorafenib was defined as the time interval measured from start date of sorafenib treatment to death due to any cause. | Up to 3 years |
| PFS from initiation of sorafenib | 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. | Up to 3 years |
| Tumor status at different visits response according to mRECIST | mRECIST: modified Response Evaluation Criteria In Solid Tumors | Up to 3 years |
| Duration of sorafenib treatment | 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). | Up to 3 years |
| TTP from initiation of sorafenib | TTP from initiation of sorafenib was defined as the time interval from start date of sorafenib treatment to the date of documented progression. | 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.
| Up to 3 years |
| Tumor response from time of TACE non-eligibility by mRECIST | Planned to be evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", and "Not evaluable" | Up 3 years |
| Switch to sorafenib or other systemic and non-systemic cancer therapy | Evaluated according to the categories "Before initial TACE", "After one TACE", "After two TACEs", and "After more than two TACEs" | Up to 3 years |
| Deviations from recommendations for TACE use | 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. | Up to 3 years |
| Duration of treatment of sorafenib after TACE | Defined as days from the first sorafenib dose to the date of permanent discontinuation of sorafenib plus one | Up to 3 years |
| Multiple Locations |
| Brazil |
| Multiple Locations | Canada |
| Multiple Locations | China |
| Multiple Locations | Czechia |
| Multiple Locations | Denmark |
| Multiple Locations | Egypt |
| Multiple Locations | France |
| Multiple Locations | Greece |
| Multiple Locations | Hong Kong |
| Multiple Locations | Hungary |
| Multiple Locations | India |
| Multiple Locations | Indonesia |
| Multiple Locations | Israel |
| Multiple Locations | Japan |
| Multiple Locations | Kazakhstan |
| Multiple Locations | Mexico |
| Multiple Locations | Netherlands |
| Multiple Locations | Pakistan |
| Multiple Locations | Poland |
| Multiple Locations | Russia |
| Multiple Locations | Singapore |
| Multiple Locations | Slovakia |
| Multiple Locations | South Korea |
| Multiple Locations | Spain |
| Multiple Locations | Sweden |
| Multiple Locations | Switzerland |
| Multiple Locations | Taiwan |
| Multiple Locations | Thailand |
| Multiple Locations | Turkey (Türkiye) |
| Multiple Locations | Vietnam |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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