Carcinoma, Hepatocellular
Conditions
Brief summary
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.
Interventions
PROCEDURETACE (transarterial chemoembolization)
First treatment for all patients included in the study
DRUGSorafenib (Nexavar, BAY43-9006)
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with histologically/cytologically documented or radiographically diagnosed HCC. 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 with BCLC (Barcelona clinic liver cancer staging) stage B or higher. * Patients in whom a decision to treat with TACE has been made at time of study enrollment. Patients that have received one TACE in the past also can be enrolled, if the TACE was done at the same site and all required data about such previous TACEs are available. TACE includes both conventional TACE with lipidiol (or similar agents) and chemotherapeutic agent(s) and TACE with DC Beads excluding TAE without chemotherapeutic agent. * Patients with unresectable HCC (incurable with curative treatments including resection or ablation or not eligible for resection or local ablation) * Patients must have signed an informed consent form * Patients must have a life expectancy of at least 8 weeks
Exclusion criteria
* Patients who have received TACE in the past but the data about TACE required in this protocol are not available * Patients who received any systemic anti-cancer therapy prior to the first TACE * Patients who are treated according to a trial protocol for intervention including a locoregional therapy or systemic therapy * Hospice patients * All contra-indications according to the local marketing authorization should be considered.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of TACE treatment | 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 |
| Deterioration of liver dysfunction | 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 \[INR\]) |
| OS from initiation of sorafenib | 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. |
| PFS from initiation of sorafenib | 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. |
| Tumor status at different visits response according to mRECIST | Up to 3 years | mRECIST: modified Response Evaluation Criteria In Solid Tumors |
| Duration of sorafenib treatment | 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). |
| TTP from initiation of sorafenib | 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. |
| Overall survival from initial TACE | 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. |
| Progression-free survival (PFS) from initial TACE | 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 to progression (TTP) from initial TACE | 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. |
| Tumor response according to mRECIST criteria | 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. |
| Number of patients with TEAEs (treatment emergent adverse events) | Up to 3 years | Patients were monitored for TEAEs using the NCI-CTCAE Version 4.03. |
| TACE unsuitability | Up to 3 years | TACE unsuitability was determined according to selected guidelines |
| Time to TACE non-eligibility | Up to 3 years | Determined according to the selected guidelines |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tumor response from time of TACE non-eligibility by mRECIST | Up 3 years | Planned to be evaluated according to the categories Complete Response, Partial Response, Stable Disease, and Not evaluable |
| Switch to sorafenib or other systemic and non-systemic cancer therapy | Up to 3 years | Evaluated according to the categories Before initial TACE, After one TACE, After two TACEs, and After more than two TACEs |
| Deviations from recommendations for TACE use | 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. |
| Duration of treatment of sorafenib after TACE | Up to 3 years | Defined as days from the first sorafenib dose to the date of permanent discontinuation of sorafenib plus one |
| PFS from TACE non-eligibility | 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. |
| TTP from TACE non-eligibility | 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. |
Countries
Austria, Brazil, Canada, China, Czechia, Denmark, Egypt, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Japan, Kazakhstan, Mexico, Netherlands, Pakistan, Poland, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Vietnam
Outcome results
None listed