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An Open Label Study of the Effect of Avastin Pre- and Post-transarterial Chemoembolisation (TACE) Treatment on Progression-free Survival in Patients With Localized Unresectable Hepatocellular Carcinoma.


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

An Open Label Study of the Effect of Avastin Pre- and Post-transarterial Chemoembolisation (TACE) Treatment on Progression-free Survival in Patients With Localized Unresectable Hepatocellular Carcinoma.


Inclusion Criteria:



- adult patients, >=18 years of age;

- liver cancer, not suitable for resection;

- at least one measurable lesion, and overall tumor lesions occupying <50% of liver
volume;

- ECOG performance status 0-2.

Exclusion Criteria:

- patients receiving concurrent radiotherapy or immunotherapy;

- patients who have received previous chemotherapy, biological agents or radiotherapy;

- prior TACE or TAE;

- prior liver transplantation or liver resection;

- current or recent (within 10 days of study start) use of full-dose anticoagulants for
therapeutic purposes;

- patients with high risk esophageal/gastric varices.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Hong Kong: Department of Health

Study ID:

ML21358

NCT ID:

NCT00576199

Start Date:

February 2008

Completion Date:

May 2011

Related Keywords:

  • Liver Cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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