Sorafenib Concomitantly Used With TACE (Transarterial Chemoembolization) in uHCC (Unresectable Hepatocellular Carcinoma) Patients in China (SUCCESS)

Study on Transarterial Chemoembolization Combined With Sorafenib in Chinese Patients With Unresectable Hepatocellular Carcinoma (SUCCESS)

This study is to obtain the characteristics and treatment pattern of the unresectable HCC patients who are candidates for systemic therapy and in whom a decision to treat with sorafenib from early stage of TACE treatment course (concomitantly use no later than the 3rd TACE procedure) has been made under real-life practice conditions.this study will also conclude the safety and effectiveness of combination in uHCC patients.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Drug: Sorafenib (Nexavar, BAY43-9006)

• Study Type: Observational
• Enrollment (Actual): 302

Contacts and Locations

Study Locations

• China
  • Multiple Locations, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Unresectable HCC patients and be candidates for concomitantly systemic therapy with sorafenib + TACE. Considering the local practice and possible clinical benefits, sorafenib should not be initiated later than 7 days after the 3rd TACE course. No prior tartgeted therapy.

Description

Inclusion Criteria:

• Patients with histologically/ cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made. 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 receive the first dose of sorafenib no later than 1 week (<=7days) after the 3rd TACE procedure
• Patients did not receive other prior systemic treatment by using target therapy
• Patients must sign the informed consent form;
• Patients must have a life expectancy of at least 3 months;
• The physician must be willing to complete and submit all CRFs;
• The physician must be willing to submit to a site audit with verification of source documents and validation of data reported;

Exclusion Criteria:

• The first dose of sorafenib 7 days after the 3nd TACE procedure
• Exclusion criteria must follow the approved local product information

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Sorafenib (Nexavar, BAY43-9006); sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summarized patient characteristics	Patient characteristics are hepatic virus infection status, surgery history, tumor size, number of tumor, macroscopic vascular invasion (MVI), extra-hepatic spread (EHS), cirrhosis, ECOG score, Child-Pugh score, BCLC stage, etc.	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolorability		up to 3 years
overall survival (OS) by the mRECIST (Modified Response Evaluation Criteria in Solid Tumor) Criteria for treatment of uHCC patients		up to 3 years
progression-free survival (PFS) by the mRECIST for treatment of uHCC patients		up to 3 years
time to progression (TTP) by the mRECIST for treatment of uHCC patients		up to 3 years
response rate (RR) by the mRECIST for treatment of uHCC patients		up to 3 years
Clinical control Rate (DCR) by the mRECIST for treatment of uHCC patients		up to 3 years
Clinical benefit rate (CBR) by the mRECIST for treatment of uHCC patients		up to 3 years
Treatment pattern of Sorafenib	Treatment pattern included: Duration and dosage of Sorafenib treatment; reason for Sorafenib dosage modification/discontinuation; anticancer combination therapy; treatment after radiographic relapse; comorbidities and their impact on disease outcome.	up to 3 years

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2013
• Primary Completion (Actual): August 6, 2016
• Study Completion (Actual): December 29, 2016

Study Registration Dates

• First Submitted: November 23, 2012
• First Submitted That Met QC Criteria: April 22, 2013
• First Posted (Estimate): April 25, 2013

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Safety; Sorafenib; Effectiveness; Hepatocellular cancer; TACE combination; Treatment pattern
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: 16608; NX1216CN (Other Identifier: company internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No