- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00241020
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
April 11, 2016 updated by: Novartis Pharmaceuticals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
270
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Octreotide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Overall Survival
|
Secondary Outcome Measures
Outcome Measure |
---|
Objective response
|
Quality of life
|
Survival without progression
|
Digestive bleeding
|
Renal insufficiency
|
· Safety
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
October 1, 2005
Study Registration Dates
First Submitted
October 14, 2005
First Submitted That Met QC Criteria
October 16, 2005
First Posted (Estimate)
October 18, 2005
Study Record Updates
Last Update Posted (Estimate)
April 12, 2016
Last Update Submitted That Met QC Criteria
April 11, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Antineoplastic Agents
- Gastrointestinal Agents
- Antineoplastic Agents, Hormonal
- Octreotide
Other Study ID Numbers
- CSMS995BFR04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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