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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Patients will be followed-up from start of Nexavar therapy until death or drop out due to any reason or end of study

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: SORINT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 25, 2013
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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