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

NCT01839630 | Completed

• 2 other identifiers: 16608NX1216CN
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Sorafenib; Hepatocellular cancer; TACE combination; Treatment pattern; Safety; Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator

Group 1

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

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.

You may qualify if:

• 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;

You may not qualify if:

• The first dose of sorafenib 7 days after the 3nd TACE procedure

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; 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: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: April 25, 2013
• Study Start: May 30, 2013
• Primary Completion: August 6, 2016
• Study Completion: December 29, 2016
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

CN (1)