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 (SORINT)
Verified January 2015 by Bayer
Information provided by (Responsible Party):
First received: July 23, 2013
Last updated: January 28, 2015
Last verified: January 2015
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.
Drug: Sorafenib (Nexavar, BAY43-9006)
||Observational Model: Cohort
Time Perspective: Prospective
||SORINT - SORafenib for Treatment of Patients With INTermediate Stage Hepatocellular Carcinoma
Primary Outcome Measures:
- 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. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
- 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). [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
- Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
- 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). [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
- Further possible prognostic factors will be evaluated. [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
- Safety variables will be summarized using descriptive statistics based on adverse events collection. [ Time Frame: up to 54 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2015 (Final data collection date for primary outcome measure)
Drug: Sorafenib (Nexavar, BAY43-9006)
Patients will be followed-up from start of Nexavar therapy until death or drop out due to any reason or end of study
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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).
- Prior targeted therapy for hepatocellular carcinoma.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908322
||Bayer Study Director
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 23, 2013
||January 28, 2015
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Bayer:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 01, 2015
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial