CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 235 enrolled
Drug / intervention
Cisplatin +9 moredrug
Likely dose
Not stated in 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/NCT01004978
NCT01004978Phase 3Completed

A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion

National Cancer Institute (NCI)·interventional·Posted Oct 30, 2009·Updated Jan 3, 2024

In Brief

A Phase 3 clinical trial evaluating Cisplatin, Computed Tomography, and 8 other interventions for Hepatocellular Carcinoma and Unresectable Hepatocellular Carcinoma. Completed, enrolled 235 participants across 281 sites.

Detailed Summary

This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Kinase inhibitors, such as sorafenib tosylate may stop the growth of tumor cells by blocking the action of an abnormal protein that signals cancer cells to multiply. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 30, 2009
Enrollment StartOct 28, 2009
Primary CompletionFeb 11, 2021
Study CompletionDec 21, 2022
TodayJul 2, 2026
Enrollment to primary: 11.3 yearsPosted 16.7 years ago

Interventions

Cisplatindrug

Undergo TACE

Computed Tomographyprocedure

Undergo CT scan

Doxorubicin Hydrochloridedrug

Undergo TACE

Doxorubicin-Eluting Beadsdrug

Undergo TACE

Laboratory Biomarker Analysisother

Correlative studies

Magnetic Resonance Imagingprocedure

Undergo MRI

Mitomycindrug

Undergo TACE

Pharmacological Studyother

Correlative studies

Placebo Administrationother

Given PO

Sorafenib Tosylatedrug

Given PO