Clinical trial NCT03644511: Use of Sorafenib and/or Regorafenib in Liver Cancer (Hepatocellular Carcinoma) Subsequent to Another Systemic First-line Treatment
Official title: Use of Sorafenib and/or Regorafenib in Hepatocellular Carcinoma (HCC) Subsequent to Another Systemic First-line Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatocellular Carcinoma
Keywords: HCC
Liver cancer
Live cell carcinoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-08-23
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with HCC in stage BCLC-B (Barcelona Classification of Liver Cancer) or BCLC-C for whom the decision to treat with Nexavar and/or Stivarga as ≥ 2nd-line has been taken by the investigator and the drugs are prescribed in the customary manner in accordance with the terms of the marketing authorization.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 24 months
Secondary outcomes:
measure: Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy
timeFrame: Up to 36 months
measure: Progression free survival (PFS)
timeFrame: Up to 36 months
measure: Time to progression (TTP)
timeFrame: Up to 36 months
measure: Duration of Nexavar or Stivarga treatment
timeFrame: Up to 36 months
measure: Tumor response to treatment
timeFrame: Up to 36 months
measure: Incidence of treatment-emergent adverse events (TEAE)
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many Locations
Study officials:
References: