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Safety Study of Sorafenib Following Combined Therapy of Radiation and TACE for Liver Cancer

NCT00999843 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-10-22

No results posted yet for this study

Summary

Patients with liver cancer will receive interventional therapy plus radiotherapy. Maintenance Sorafenib will be taken after the completion of radiotherapy. Hypothesis of the current study is that Sorafenib as a maintenance therapy is safe and superior to radiotherapy combined with interventional therapy in terms of survival in comparison to historical data.

Conditions

Interventions

DRUG

Sorafenib

Sorafenib is administered only to the patients with non-progression disease (CR, PR and SD) 4 weeks after the completion of radiotherapy. The dose is 400 mg, p.o., twice a day. Sorafenib is continuously given for 12 months unless intolerable toxicities and/or tumor progression.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Guo-liang Jiang, M.D. · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-10-31
Completion
2012-10-31

Countries

  • China

Study Locations

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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 NCT00999843 on ClinicalTrials.gov