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

Carcinoma, Hepatocellular Clinical Trial

— SORINT  

Official title:

SORINT - SORafenib for Treatment of Patients With INTermediate Stage Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908322
• Other study ID #: 16628
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: November 10, 2015
• Start date: August 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		up to 54 months	No
Primary	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).		up to 54 months	No
Secondary	Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason.		up to 54 months	No
Secondary	Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.		up to 54 months	No
Secondary	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.		up to 54 months	No
Secondary	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.		up to 54 months	No
Secondary	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).		up to 54 months	No
Secondary	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.		up to 54 months	No
Secondary	Further possible prognostic factors will be evaluated.		up to 54 months	No
Secondary	Safety variables will be summarized using descriptive statistics based on adverse events collection.		up to 54 months	Yes

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