Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

Bayer

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Placebo; Drug: Nexavar (Sorafenib, BAY43-9006)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00692770

12414

2008-001087-36 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 1,114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,114 participants in 2 patient groups, including a placebo group

Sorafenib (Nexavar, BAY43-9006)

Experimental group

Description:

Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)

Treatment:

Drug: Nexavar (Sorafenib, BAY43-9006)

Placebo

Placebo Comparator group

Description:

Participants received 2 tablets of placebo orally twice daily (BID)

Treatment:

Drug: Placebo