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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)

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ClinicalTrials.gov Identifier: NCT01908322
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : November 11, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Drug: Sorafenib (Nexavar, BAY43-9006)

Study Design

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SORINT - SORafenib for Treatment of Patients With INTermediate Stage Hepatocellular Carcinoma
Study Start Date : August 2013
Primary Completion Date : June 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Further possible prognostic factors will be evaluated. [ Time Frame: up to 54 months ]
  8. Safety variables will be summarized using descriptive statistics based on adverse events collection. [ Time Frame: up to 54 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908322

Many Locations, Germany
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01908322     History of Changes
Other Study ID Numbers: 16628
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015

Keywords provided by Bayer:
Hepatocellular carcinoma
Intermediate stage
Observational study

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action