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A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.

Phase 3
18 Years
Open (Enrolling)
Carcinoma, Hepatocellular

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Trial Information

A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Recurrence Free Survival

Outcome Time Frame:

approximately 70 months from first patient first visit

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:




Start Date:

August 2008

Completion Date:

March 2020

Related Keywords:

  • Carcinoma, Hepatocellular
  • Hepatocellular carcinoma
  • Sorafenib
  • Adjuvant
  • Surgical resection
  • Ablation
  • Nexavar
  • Adjuvant therapy
  • Liver cancer
  • HCC
  • Carcinoma
  • Carcinoma, Hepatocellular



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