Overview

This trial is active, not recruiting.

Condition carcinoma, hepatocellular
Treatments nexavar (sorafenib, bay43-9006), placebo
Phase phase 3
Sponsor Bayer
Start date August 2008
End date November 2013
Trial size 1114 participants
Trial identifier NCT00692770, 12414, 2008-001087-36

Summary

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
nexavar (sorafenib, bay43-9006)
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.
(Placebo Comparator)
placebo
400mg (2 x 200mg tablets) orally, twice a day, continuously , until disease recurrence or unacceptable toxicity or other criteria for withdrawal are met.

Primary Outcomes

Measure
Recurrence Free Survival
time frame: approximately 70 months from first patient first visit

Secondary Outcomes

Measure
Time to recurrence
time frame: approximately 70 months from first patient first visit
Overall survival
time frame: approximately 140 months from first patient first visit
Patient-Reported Outcome (PRO) as assessed by FACT-Hep and EQ-5D questionnaire.
time frame: approximately 70 months from first patient first visit
Evaluation of biomarkers.
time frame: approximately 70 months from first patient first visit

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period. - At least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date - Male or female subjects >/= 18 years of age - Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review. - For subjects undergoing surgical resection pathology proven complete removal of tumor. - Intermediate or High Risk of recurrence as assessed by tumor characteristics. - Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites. - ECOG Performance Status of 0. - Adequate bone marrow, liver and renal function Exclusion Criteria: - Recurrent HCC - Child-Pugh score 7 points with presence of ascites. - Low risk of recurrence after curative treatment - History of cardiovascular disease - History of HIV infection - Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0) - Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics) - Subjects with evidence or history of bleeding diathesis - Subjects undergoing renal dialysis - Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry as defined by the signing of informed consent.. - Uncontrolled ascites (defined as not easily controlled with diuretic treatment) - Encephalopathy - History of GI bleeding within 30 days of randomization. - Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence. - Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded. - Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC. - Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent. - Liver transplantation, this includes patients on a transplant list with the intention to transplant

Additional Information

Official title A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Bayer.