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OpenTrials
Completed

NCT Number: NCT00241020

Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

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.

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Key information

Conditions

Advanced Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Octreotide

Drug

Primary outcomes

  1. Overall Survival

Secondary outcomes

  1. Objective response

  2. Survival without progression

  3. Digestive bleeding

  4. Renal insufficiency

  5. Quality of life

  6. · Safety

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Oct 18, 2005
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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