Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Nexavar (Sorafenib, BAY43-9006); Placebo
Intervention description: Sorafenib 400 mg twice daily (BID); Placebo 2 tablets twice daily (BID)
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatocellular carcinoma; Sorafenib; Adjuvant; Surgical resection; Ablation; Nexavar; Adjuvant therapy; Liver cancer; HCC; STORM

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).
    

Eligibility criteria:

        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