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

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Procedure: TACE (transarterial chemoembolization); Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT01933945
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-02
• Study Start: 2013-10-28
• Primary Completion: 2017-07-22
• Study Completion: 2017-11-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1676

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TACE + early Nexavar	TACE (transarterial chemoembolization)	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 without early Nexavar	TACE (transarterial chemoembolization)	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 + early Nexavar	Sorafenib (Nexavar, BAY43-9006)	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).

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 3 years	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) from initial TACE	Up to 3 years	PFS from initial TACE was defined as the time interval measured from the day of the first TACE to documented (radiological or clinical) progression or death, whichever came first.
Duration of TACE treatment	Up to 3 years	Duration of TACE treatment was defined as the time interval from of the day of first TACE to the date of permanent discontinuation of TACE
TTP from initiation of sorafenib	Up to 3 years	TTP from initiation of sorafenib was defined as the time interval from start date of sorafenib treatment to the date of documented progression.
Overall survival from initial TACE	Up to 3 years	OS from initial TACE was defined as the time interval from the day of the first TACE to death due to any cause.
Time to progression (TTP) from initial TACE	Up to 3 years	TTP from initial TACE was defined as the time interval from the day of first TACE to the date of documented progression.
Tumor response according to mRECIST criteria	Up to 3 years	Tumor response to TACE by modified Response Evaluation Criteria In Solid Tumors (mRECIST) were evaluated according to the categories "Complete Response", "Partial Response", "Stable Disease", and "Not evaluable" by mRECIST for each TACE.
Number of patients with TEAEs (treatment emergent adverse events)	Up to 3 years	Patients were monitored for TEAEs using the NCI-CTCAE Version 4.03.
Time to TACE non-eligibility	Up to 3 years	Determined according to the selected guidelines
OS from initiation of sorafenib	Up to 3 years	OS from initiation of sorafenib was defined as the time interval measured from start date of sorafenib treatment to death due to any cause.
Tumor status at different visits response according to mRECIST	Up to 3 years	mRECIST: modified Response Evaluation Criteria In Solid Tumors
Duration of sorafenib treatment	Up to 3 years	Duration of sorafenib treatment was defined as the time interval from start date of sorafenib treatment to the date of permanent discontinuation of sorafenib treatment (regardless of the reason for discontinuation including death).
Deterioration of liver dysfunction	Up to 3 years	Deteriorations of liver dysfunction were defined as follow: Deterioration of Child Pugh score (A5, A6, B7, B8, B9); Liver dysfunction reported as AE or deterioration of aspartate aminotransferase, alanine aminotransferase or bilirubin (from Grade 1 to Grade 2-5, from Grade 2 to 3-5, Grade 3 to Grade 4 or 5); Any liver related adverse events or deterioration of liver related events according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03; Change of liver related laboratory data (aspartate aminotransferase, alanine aminotransferase, bilirubin, albumin, prothrombin international normalized ratio \[INR\])
PFS from initiation of sorafenib	Up to 3 years	PFS from initiation of sorafenib was defined as the time interval measured from the start date of sorafenib treatment to documented (radiological or clinical) progression or death, whichever came first.
TACE unsuitability	Up to 3 years	TACE unsuitability was determined according to selected guidelines