Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib

NCT01933945 | Completed

• 2 other identifiers: 16560NX1301
• Study Type: observational
• Target: 1,676
• Locations: 31 countries
• Sites: 31

Brief Summary

This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Defined as time (in days) from time of TACE non-eligibility to death due to any cause. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.

  Up to 3 years

Secondary Outcomes (14)

• Overall survival from initial TACE

  Up to 3 years

• Progression-free survival (PFS) from initial TACE

  Up to 3 years

• Time to progression (TTP) from initial TACE

  Up to 3 years

• Tumor response according to mRECIST criteria

  Up to 3 years

• Duration of TACE treatment

  Up to 3 years

Other Outcomes (6)

• PFS from TACE non-eligibility

  Up to 3 years

• TTP from TACE non-eligibility

  Up to 3 years

• Tumor response from time of TACE non-eligibility by mRECIST

  Up 3 years

Study Arms (2)

TACE + early Nexavar

Patients with early start of Sorafenib treatment. This cohort comprises all patients where the physician decides at the time of TACE non-eligibility to choose Sorafenib as the next treatment option (regardless of whether TACE treatment is continued or not).

Procedure: TACE (transarterial chemoembolization); Drug: Sorafenib (Nexavar, BAY43-9006)

TACE without early Nexavar

Patients without early start of Sorafenib treatment. This cohort comprises all patients where the physician decides at the time of TACE non-eligibility not to choose Sorafenib as the next treatment option. This cohort also includes patients with TACE non-eligibility for whom the decision to treat with Sorafenib is made at a later point in time, patients who are never treated with Sorafenib as well as patients for whom another systemic cancer treatment has been chosen be the physician either at time of TACE non-eligibility or at a later point in time.

Procedure: TACE (transarterial chemoembolization)

Interventions

TACE (transarterial chemoembolization) PROCEDURE

First treatment for all patients included in the study

TACE + early Nexavar; TACE without early Nexavar

Sorafenib (Nexavar, BAY43-9006) DRUG

TACE + early Nexavar

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female and male patients with a diagnosis of hepatocellular carcinoma (HCC) will be enrolled in the participating study countries and sites during the enrollment period. All treatment decisions prior inclusion of a patient as well as during the observation must be made by the investigator based on his regular medical practice. Patients must give written informed consent prior to documentation. During the course of the study, patients will be assigned to one of the following cohorts of special interest: 1. Patients with early start of sorafenib treatment 2. Patients without early start of sorafenib treatment.

You may qualify if:

• Patients with histologically/cytologically documented or radiographically diagnosed HCC. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI.
• Patients with BCLC (Barcelona clinic liver cancer staging) stage B or higher.
• Patients in whom a decision to treat with TACE has been made at time of study enrollment. Patients that have received one TACE in the past also can be enrolled, if the TACE was done at the same site and all required data about such previous TACEs are available. TACE includes both conventional TACE with lipidiol (or similar agents) and chemotherapeutic agent(s) and TACE with DC Beads excluding TAE without chemotherapeutic agent.
• Patients with unresectable HCC (incurable with curative treatments including resection or ablation or not eligible for resection or local ablation)
• Patients must have signed an informed consent form
• Patients must have a life expectancy of at least 8 weeks

You may not qualify if:

• Patients who have received TACE in the past but the data about TACE required in this protocol are not available
• Patients who received any systemic anti-cancer therapy prior to the first TACE
• Patients who are treated according to a trial protocol for intervention including a locoregional therapy or systemic therapy
• Hospice patients
• All contra-indications according to the local marketing authorization should be considered.

Sponsors & Collaborators

• Bayer: lead

Study Sites (31)

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Multiple Locations, Austria

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Multiple Locations, Brazil

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Multiple Locations, Canada

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Multiple Locations, China

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Multiple Locations, Czechia

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Multiple Locations, Denmark

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Multiple Locations, Egypt

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Multiple Locations, France

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Multiple Locations, Greece

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Multiple Locations, Hong Kong

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Multiple Locations, Hungary

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Multiple Locations, India

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Multiple Locations, Indonesia

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Multiple Locations, Israel

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Multiple Locations, Japan

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Multiple Locations, Kazakhstan

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Multiple Locations, Mexico

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Multiple Locations, Netherlands

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Multiple Locations, Pakistan

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Multiple Locations, Poland

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Multiple Locations, Russia

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Multiple Locations, Singapore

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Multiple Locations, Slovakia

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Multiple Locations, South Korea

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Multiple Locations, Spain

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Multiple Locations, Sweden

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Multiple Locations, Switzerland

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Multiple Locations, Taiwan

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Multiple Locations, Thailand

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Multiple Locations, Turkey (Türkiye)

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Multiple Locations, Vietnam

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Related Links

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 2, 2013
• Study Start: October 28, 2013
• Primary Completion: July 22, 2017
• Study Completion: November 10, 2017
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

TU (1); HK (1); DK (1); PA (1); TW (1); SE (1); TH (1); GR (1); IL (1); SL (1); CH (1); VN (1); ME (1); ES (1); CA (1); ID (1); BR (1); KA (1); KR (1); CN (1); EG (1); RU (1); AU (1); JP (1); SG (1); NL (1); IN (1); PL (1); CZ (1); HU (1); FR (1)