A Phase III randomized, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation.Estudio Fase III, aleatorizado, doble ciego, controlado con placebo, de sorafenib como tratamiento adyuvante para carcinoma hepatocelular tras resección quirúrgica o ablación local. - STORM
- Conditions
- To evaluate clinical benefits of sorafenib vs placebo as adujuvant treatment in subjects with HCC who received potentially curative treatment (surgical resection or local ablation).Evaluar la eficacia y seguridad de sorafenib frente a placebo en el tratamiento adyuvante del carcinoma hepatocelular (CHC) después del tratamiento potencialmente curativo con resección quirúrgica o ablación local.MedDRA version: 9.1Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectable
- Registration Number
- EUCTR2008-001087-36-ES
- Lead Sponsor
- Bayer Healthcare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1100
?Informed consent
?Confirmation of diagnosis of HCC:
?for subjects undergoing surgical resection histological confirmation is mandatory (a post surgery pathology report is required for both histological confirmation and risk stratification).
?for subjects undergoing local ablation either histological confirmation or clinical diagnosis by AASLD criteria in cirrhotic subjects is required. For subjects without cirrhosis histological confirmation is mandatory.
Prior to curative treatment, confirmation of a maximum tumor load of:
?single lesion any size for surgical resection, or
single lesion ? 5cm (largest diameter, unidimensional measurement) for local ablation
?2-3 lesions, each ? 3 cm in size (largest diameter, unidimensional measurement)
?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.
?4 weeks (28 days ± 7 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 as assessed by central lab by means of the following laboratory requirements from samples approximately 14 days prior to randomization:
?Alpha fetoprotein < 400 ng/mL
?Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of treatment (assessed centrally).
?Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
?No more than 4 weeks (28 days ± 7 days) from the eligibility scan date (CT or MRI) to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
?Recurrent HCC
?Child-Pugh score 7 points with presence of ascites.
?The following tumor characteristics:
a)Low risk of recurrence after curative treatment defined as any of the following:
?for local ablation patients: single lesions < 2 cm
?for surgical resection patients: single lesions < 2 cm without microscopic vascular invasion, without tumor satellites and histologically well differentiated.
b)> 3 lesions or 2-3 lesions of which any are > 3 cm in size (largest diameter, unidimensional measurement) prior curative treatment (surgical resection or local ablation)
c)single lesion > 5 cm (largest diameter, unidimensional measurement) in size prior local ablation.
d)Macrovascular invasion
e)Extrahepatic spread (including regional lymph nodes and invasion into adjacent structures)
?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)
?History of organ allograft
?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.
?Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
?Encephalopathy
?History of GI bleeding within 30 days.
?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, except for surgical resection or local ablation of HCC.
?Autologous bone marrow transplant or stem cell rescue within 4 months of study
?Use of biologic response modifiers, such as G-CSF, within 3 week of study entry.
?Investigational drug therapy outside of this trial during or within 4 weeks of study entry
?Pregnant or breast-feeding subjects.
?Substance abuse, medical, psychological or social conditions that may interfere with the subject?s participation in the study or evaluation of the study results
?Known or suspected allergy to sorafenib.
?Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
?Subjects unable to swallow oral medications. This applies to subjects with severe obstruction of the upper GI tract that require gavage.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method