Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

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.

Conditions

• Hepatocellular Carcinoma
• Unresectable Hepatocellular Carcinoma

Interventions

DRUG

Cisplatin

Undergo TACE

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Doxorubicin Hydrochloride

Undergo TACE

DRUG

Doxorubicin-Eluting Beads

Undergo TACE

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Mitomycin

Undergo TACE

OTHER

Pharmacological Study

Correlative studies

OTHER

Placebo Administration

Given PO

DRUG

Sorafenib Tosylate

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Al B Benson · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-28

Primary Completion

2021-02-11

Completion

2022-12-21

Countries

• United States

Study Locations