Hepatocellular Carcinoma
Conditions
Keywords
HCC, Liver cancer, Live cell carcinoma
Brief summary
Researchers already did trials that showed Sorafenib and Regorafenib worked for patients with hepatocellular carcinoma (most common liver tumor type). In this trial, they want to learn more about the same patient group in which Sorafenib or Regorafenib is given after other drugs. Patients participating in this study will be observed until 12 months after the last patient has been enrolled to collect data on how safe the drugs are and how well they are working when used as second line or beyond treatment.
Interventions
DRUGRegorafenib (Stivarga, BAY73-4506)
Prescribed by physician.
DRUGSorafenib (Nexavar, BAY43-9006)
Prescribed by physician.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of hepatocellular cancer in stage BCLC-B or BCLC-C * Decision to initiate treatment with Nexavar (sorafenib) and/or Stivarga (regorafenib) as 2nd-line or beyond treatment was made as per investigator's routine treatment practice. Stivarga (regorafenib) must be used according to its indication, i.e. after prior progression under Nexavar (sorafenib) treatment.
Exclusion criteria
* Patients concurrently participating in an investigational program for the treatment of HCC with interventions outside of routine clinical practice. * Stivarga (regorafenib) treatment without prior therapy with Nexavar (sorafenib). NOTE: Nexavar (sorafenib) treatment could have been given as treatment for HCC outside of this non-interventional study. In this case Stivarga (regorafenib) would NOT constitute the second-line therapy after direct pretreatment with Nexavar (sorafenib) but e.g. 3rd-line treatment directly after a different drug. * Contra-indications according to the local marketing authorization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of current treatment patterns by means of individual treatment lines in the systemic HCC therapy with regards to Nexavar and Stivarga, i.e. when both drugs are used in ≥ 2nd-line under current practice conditions | Up to 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | Up to 36 months | — |
| Time to progression (TTP) | Up to 36 months | — |
| Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy | Up to 36 months | — |
| Tumor response to treatment | Up to 36 months | Evaluated by the investigator according to the categories complete response, partial response, stable disease, progressive disease by clinical judgment, progressive disease measurement proven, unknown and not applicable, and will be analyzed providing absolute and relative frequencies of the tumor status categories. |
| Incidence of treatment-emergent adverse events (TEAE) | Up to 36 months | — |
| Duration of Nexavar or Stivarga treatment | Up to 36 months | — |
Countries
Germany
Outcome results
None listed