Informations générales (source: ClinicalTrials.gov)
Phase II Study Evaluating the Efficacy of Bevacizumab (Avastin@) in Hepatocellular Carcinoma Not Amenable to Curative Treatment
Interventional
Phase 2
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
mai 2005
29 juin 2024
Primary liver cancer (hepatocellular carcinoma) is the fifth most common malignant
disorder, with an increasing incidence in Europe and the USA as a result of the high
prevalence of hepatitis C. Most patients are not suitable for potentially curative
treatment. There is no standard palliative treatment for patients with advanced
hepatocellular carcinoma (HCC), as no drug has been demonstrated to be efficient in this
disease in terms of survival. The use of anti-vascular agents might be a promising
approach in view of the highly vascular nature of this tumor. The aim of this phase II
trial is to evaluate the potential benefit of bevacizumab in terms of disease control
rate, progression-free and overall survival in adult patients with advanced primary liver
cancer. Bevacizumab is an angiogenesis inhibitor already successfully used in patients
with colorectal and renal cancers.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Valérie BOIGE, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
ablation)
- 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
- 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
ablation)
- 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
- 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
potential.