MedTrace Logo

Sorafenib Chemoembolization Evaluation Controlled Trial

NCT01906216 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2024-08-28

No results posted yet for this study

Summary

This prospective, multicenter, randomized, controlled study aims to evaluate the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) in advanced hepatocellular carcinoma (HCC) patients compared with sorafenib alone, and to determine the prognostic factors that influence the survival.

Data on the efficacy and safety of sorafenib in combination with TACE in patients with advanced HCC are lacking. Because in western countries, advanced HCC is considered as a contraindication for TACE treatment. However, clinical practice patterns differ markedly between Asia and western countries: in Asia TACE is performed in selected advanced HCC patients. We consider sorafenib combined with TACE could achieve better survival benefit than sorafenib alone in selected advanced HCC patients.

Conditions

Interventions

DRUG

Sorafenib

Sorafenib will be supplied as 200 mg tablets. All subjects will take two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening).

PROCEDURE

TACE

The first treatment of TACE should be completed within 3-7 days after the administration of sorafenib started. In all cases, TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) or beads until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible. TACE will be repeated "on demand" depending on the radiological response.

Sponsors & Collaborators

  • Air Force Military Medical University, China

    lead OTHER

Principal Investigators

  • Guohong Han, MD，PhD · Xijing Hospital of Digestive Disease, Fourth Military Medical University

  • Guohong Han, MD，PhD · Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01906216 on ClinicalTrials.gov