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Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma

NCT01556815 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-04-25

No results posted yet for this study

Summary

Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.

Conditions

  • PHENYTOIN/SORAFENIB [VA Drug Interaction]
  • Liver Neoplasms
  • Carcinoma, Hepatocellular
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Liver Diseases
  • Adenocarcinoma
  • Carcinoma
  • Neoplasms, Glandular and Epithelial
  • Neoplasms by Histologic Type
  • DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction]
  • HBV

Interventions

PROCEDURE

Transarterial Chemoembolization (TACE)

Procedure:TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .

OTHER

Sorafenib in combination with TACE

Drug: Sorafenib All patients will receive Sorafenib (800 mg/day) p.o. beginning one week after the first TACE and every day thereafter until patient death or premature withdrawal from study. Procedure: TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Principal Investigators

  • Jinlong Song, MD · Shandong Cancer Hospital and Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-05-31
Completion
2015-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT01556815 on ClinicalTrials.gov