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

NCT ID: NCT01933945

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1676 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-28
• Study Completion Date: 2017-11-10

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

TACE (transarterial chemoembolization)

Intervention Type: PROCEDURE

First treatment for all patients included in the study

Sorafenib (Nexavar, BAY43-9006)

Intervention Type: DRUG

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.

TACE (transarterial chemoembolization)

Intervention Type: PROCEDURE

First treatment for all patients included in the study

Interventions

TACE (transarterial chemoembolization)

First treatment for all patients included in the study

Intervention Type: PROCEDURE

Sorafenib (Nexavar, BAY43-9006)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Multiple Locations, , Austria

Multiple Locations, , Brazil

Multiple Locations, , Canada

Multiple Locations, , China

Multiple Locations, , Czechia

Multiple Locations, , Denmark

Multiple Locations, , Egypt

Multiple Locations, , France

Multiple Locations, , Greece

Multiple Locations, , Hong Kong

Multiple Locations, , Hungary

Multiple Locations, , India

Multiple Locations, , Indonesia

Multiple Locations, , Israel

Multiple Locations, , Japan

Multiple Locations, , Kazakhstan

Multiple Locations, , Mexico

Multiple Locations, , Netherlands

Multiple Locations, , Pakistan

Multiple Locations, , Poland

Multiple Locations, , Russia

Multiple Locations, , Singapore

Multiple Locations, , Slovakia

Multiple Locations, , South Korea

Multiple Locations, , Spain

Multiple Locations, , Sweden

Multiple Locations, , Switzerland

Multiple Locations, , Taiwan

Multiple Locations, , Thailand

Multiple Locations, , Turkey (Türkiye)

Multiple Locations, , Vietnam

Countries

Austria; Brazil; Canada; China; Czechia; Denmark; Egypt; France; Greece; Hong Kong; Hungary; India; Indonesia; Israel; Japan; Kazakhstan; Mexico; Netherlands; Pakistan; Poland; Russia; Singapore; Slovakia; South Korea; Spain; Sweden; Switzerland; Taiwan; Thailand; Turkey (Türkiye); Vietnam

Related Links

https://clinicaltrials.bayer.com/

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Other Identifiers

NX1301

Identifier Type: OTHER

Identifier Source: secondary_id

16560

Identifier Type: -

Identifier Source: org_study_id