Advanced Hepatocellular Carcinoma
Conditions
Keywords
hepatocellular carcinoma, Octreotide
Brief summary
Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. For patients with advanced HCC no efficient treatment is currently available. The objective of this study is to assess the efficacy and safety of octreotide in patients with advanced hepatocellular carcinoma.
Interventions
DRUGOctreotide
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years * HCC diagnosis : * histologically or cytologically proven HCC * or association of the three following criteria: * cirrhosis * typical measurable mass (\> 3cm, by 2 methods) * serum alpha-foetoprotein (AFP) ≥500 µg/L * Cancer Liver Italian Program (CLIP) score : 0 to 3 * Not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization)
Exclusion criteria
* Glycemia \> 2.5 g/L or hypoglycemia * Extra hepatic life-threatening disease * Serum creatinin\> 120 µmol/L * Prothrombin time \< 50 % * Platelet count \< 50.000 /µL * Symptomatic cholelithiasis * Non-measurable tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival without progression | — |
| Digestive bleeding | — |
| Objective response | — |
| Quality of life | — |
| · Safety | — |
| Renal insufficiency | — |
Outcome results
None listed