At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed hepatocellular carcinoma (HCC)
- ✓At least one measurable tumor lesion by RECIST that has not received prior local therapy
- ✓Life expectancy of at least 12 weeks
- ✓Age 18 years or older
- ✕Prior or concurrent cancer with different primary site or histology from HCC (exceptions: cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis, T1], or any cancer curatively treated >3 years prior)
- ✕Renal failure requiring hemodialysis or peritoneal dialysis
- ✕History of cardiac disease
- ✕Active clinically serious infections
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
In Brief
A Phase 3 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) and Placebo for Carcinoma, Hepatocellular. Completed, enrolled 602 participants across 178 sites in 23 countries.
Detailed Summary
The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.
Study Details
Timeline
Interventions
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.
Sorafenib-matching placebo tablets were orally administered twice daily (bid).