Sorafenib for Residue Disease After Resection With Curative Intent (SECURE)

Investigations of Sorafenib for HCC Patients Who Have Residue Disease After Resection With Curative Intent

Radical hepatic resection represents one of the treatment options offering a prospect for cure with 5-year survival rates up to 50%. However, unintentionally, quite a proportion of these "radical resection" actually turned out to be non-radical in nature. For these patients who actually received non-radical resection, their by year survival rates were much lower than those who received radical hepatectomy. In this prospective, non-interventional, multi-center study, we are planning to observe the patient characteristics of Hepatocellular carcinoma (HCC) patients who have residual disease after resection with curative intent, as well as treatment pattern, safety and effectiveness of sorafenib for these patients.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• China
  • Many Locations, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HCC patients with residue disease after resection with curative intent

Description

Inclusion Criteria:

• Patients with histologically confirmed HCC and have residual disease after resection with curative intent and for whom a decision to treat with Sorafenib has been made.

The definitions of non-radical resection are as follows:

Liver tumor rupture or adjacent organ invasion, confirmed by intra-operative or post-operative pathology; Positive resection margin, confirmed by post- operative pathology; Lymph node metastasis confirmed by intra-operative or post- operative pathology; Residue lesion confirmed by post-operative digital subtraction angiography (DSA); Macroscopic/microscopic tumor thrombi of vein and/or bile duct, confirmed intraoperative / post-operative pathology; Number of tumors >=3, confirmed by preoperative radiographic inspection (CT, MRI or BUS), intraoperative BUS, or post-operative pathology.

AFP alpha fetoprotein(AFP) remains higher than Upper Limits of Normal (according to local lab's range), confirmed by local laboratory test at least 2 months after surgery.

• Confirmation of complete response (no visible residual tumor), on the eligibility scan (CT or MRI) by local radiological review, performed >2 weeks after surgery;
• Patients must be followed up regularly after surgery (time interval and method based on physician's daily practice), have no documented tumor recurrence by eligibility scan (CT or MRI) before Sorafenib treatment;
• Patients must have physically/mentally recovered from surgery and considered to be able to tolerant Sorafenib therapy, by investigator's judgment;

Exclusion Criteria:

• The approved local product label must be followed for the exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient characteristics: demographic, baseline characteristic, HCC diagnosis, prior HCC treatment, tumor status at operation, hepatic resection, time interval between surgery and Sorafenib, postoperative anti HCC treatment if any, past medical history	up to 1 year
Treatment pattern of Sorafenib: duration and doses of Sorafenib, dose modification/discontinuation of Sorafenib, concomitant anti-cancer therapy, treatment after observed radiological recurrence.	up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	up to 3 years
Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability	up to 3 years
Disease-free survival (DFS)	up to 3 years
Recurrence rate by year	up to 3 years
survival rate by year	up to 3 years
Time to recurrence (TTR)	up to 3 years

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2013
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): September 8, 2017

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 18, 2012

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib
• Other Study ID Numbers: 16621; NX1218CN (Other Identifier: company internal)