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Phase II Study Evaluating the Efficacy of Bevacizumab (Avastin@) in Hepatocellular Carcinoma Not Amenable to Curative Treatment

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Phase II Study Evaluating the Efficacy of Bevacizumab (Avastin@) in Hepatocellular Carcinoma Not Amenable to Curative Treatment

Inclusion Criteria:

- Histologically or cytologically proven HCC or alpha-fetoprotein level > 400 ng/ml
together with hypervascular tumor and cirrhosis documented by CT scan or MRI.

- HCC not amenable to curative treatment (resection, transplantation, percutaneous

- Presence of at least one dimensionally measurable target lesion with largest diameter
>= 2 cm.

- No previous chemoembolization, no previous radiotherapy

- Cancer of the Liver Italian Program (CLIP) score < 4

- World Health Organization (WHO) performance status of 2 or less

- Life expectancy >= 3 months.

- Age >= 18 years.

- Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter;
platelet count, at least 75,000 per cubic millimetre; Hemoglobin, at least 8 g/dl)

- Adequate liver function (bilirubin, not more than 2 times the upper limit of normal);
Adequate renal function (serum creatinine, less than 150 micromol per liter)

- Adequate coagulation function

- Written informed consent

Exclusion Criteria:

- Decompensated cirrhosis (Child-Pugh score > 7)

- CLIP score > 4

- Variceal bleeding during the previous 3 months

- Thromboembolic event during the previous 6 months

- Medical condition requiring full dose anticoagulation or anti-platelet drugs

- Abnormal cardiac function with history of ischemic heart disease in the previous 6
months, uncontrolled hypertension, unstable angina, severe cardiac arrhythmia,

- No brain metastasis, No bone metastasis only

- Previous or current malignancies at other sites

- No concomitant antitumor treatment including tamoxifen or somatostatin analogs

- Unstable systemic diseases or active uncontrolled infections.

- Patients (male and female) not using effective contraception if of reproductive

Type of Study:


Study Design:

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

Outcome Measure:

The main response parameter will be the disease control rate, defined by the objective response and stable disease rate (Response Evaluation Criteria in Solid Tumors [RECIST criteria]) after two consecutive tumor evaluations during treatment.

Principal Investigator

Valérie BOIGE, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IGR 1123



Start Date:

May 2005

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular carcinoma, advanced, bevacizumab, phase II, VGEF, neovascularization
  • Carcinoma
  • Carcinoma, Hepatocellular