CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
sorafenib +1 moredrug
Likely dose
sorafenib 400 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/NCT00844883
NCT00844883Phase 2Completed
CompareCT.gov

Phase II Trial of Sorafenib Combined With Doxorubicin Eluting Bead-Transarterial Chemoembolization (LC Bead-TACE) for Patients With Hepatocellular Carcinoma

Yale University·interventional·Posted Feb 16, 2009·Updated Nov 11, 2021

In Brief

A Phase 2 clinical trial evaluating sorafenib and LC Bead-TACE for Hepatocellular Carcinoma and Hepatoma. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This study will combine two therapies to treat patients with unresectable hepatocellular carcinoma; sorafenib, and drug eluting beads delivered intra-arterially. The purpose of the study is to establish the safety and the effectiveness of the combination therapy. The investigators hypothesize that the combination of the two therapies will not result in greater toxicities to patients than that expected for either therapy given alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma, Hepatoma
CountriesUnited States
CollaboratorsBayer, Biocompatibles UK Ltd

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 16, 2009
Enrollment StartFeb 1, 2009
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 17.4 years ago

Interventions

sorafenibdrug

sorafenib: given 400 mg twice per day for as long as it is beneficial

LC Bead-TACEprocedure

LC Beads loaded with doxorubicin Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period