CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 307 enrolled
Drug / intervention
Sorafenib (Nexavar, BAY43-9006) +1 moredrug
Likely dose
Sorafenib (Nexavar, BAY43-9006) 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00855218
NCT00855218Phase 2Completed
CompareCT.gov

A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

Bayer·interventional·Posted Mar 4, 2009·Updated Aug 18, 2017

In Brief

A Phase 2 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) and Placebo for Carcinoma, Hepatocellular. Completed, enrolled 307 participants across 107 sites in 13 countries.

Detailed Summary

This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesAustralia, Austria, Belgium, Canada, China, France, Germany, Italy, Singapore, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 4, 2009
Enrollment StartMar 1, 2009
Primary CompletionJul 1, 2011
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.3 years ago

Interventions

Sorafenib (Nexavar, BAY43-9006)drug

800 mg sorafenib (4 tablets) will be taken daily (400mg b.i.d. \[twice daily\], 2 tablets). Transarterial Chemoembolization (TACE) using DC Bead

Placebodrug

4 tablets of placebo will be taken daily (2 tablets b.i.d). TACE using DC Bead