Clinical trial NCT01908322: Investigating Patient Characteristics of Intermediate Stage Hepatocellular Carcinoma Patients Treated With Nexavar and Their Distribution to Different Treatment Groups as Well as Determining Effectiveness and Safety
Official title: SORINT - SORafenib for Treatment of Patients With INTermediate Stage Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular carcinoma
Intermediate stage
Observational study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-07-25
Enrollment: 19
Sex: ALL
Standard ages: CHILD
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 intermediate stage hepatocellular carcinoma (BCLC-B) treated with Nexavar according to the local summary of product characteristics. Participants will be recruited from oncological and gastroenterological clinics and practices throughout Germany.

In this non-interventional observational study, the decision on the duration and dosage of treatment is solely at the discretion of the attending physician.

The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.

Brief summary: The study aims to investigate patient characteristics of intermediate stage hepatocellular carcinoma patients treated with Nexavar and their distribution to different treatment groups as well as determining efficacy and safety parameters.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of unresectable intermediate stage hepatocellular carcinoma (BCLC-B) for whom the decision has been taken by the investigator to prescribe Nexavar (the BCLC intermediate stage (BCLC-B) consists of Child-Pugh A and B patients with large/multifocal HCC who do not have cancer related symptoms, macrovascular invasion or extrahepatic spread).

Exclusion Criteria:

- Prior targeted therapy for hepatocellular carcinoma.

Primary outcomes:
measure: Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group.
timeFrame: up to 54 months
measure: Characteristics of patients with intermediate stage HCC (BCLC-B) treated with Nexavar will be determined by evaluating demographic data, medical history, previous treatment of HCC, specific concomitant conditions (amongst others).
timeFrame: up to 54 months
Secondary outcomes:
measure: Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason.
timeFrame: up to 54 months
measure: Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.
timeFrame: up to 54 months
measure: Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first.
timeFrame: up to 54 months
measure: Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity.
timeFrame: up to 54 months
measure: Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation).
timeFrame: up to 54 months
measure: Tumor status at different visits will be evaluated according to radiological or clinical evaluation. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.
timeFrame: up to 54 months
measure: Further possible prognostic factors will be evaluated.
timeFrame: up to 54 months
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection.
timeFrame: up to 54 months
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: