Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT00241020
Last Updated: 2016-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2002-06-30
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Octreotide
Octreotide
Interventions
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Octreotide
Eligibility Criteria
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Inclusion Criteria
* 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
* Extra hepatic life-threatening disease
* Serum creatinin\> 120 µmol/L
* Prothrombin time \< 50 %
* Platelet count \< 50.000 /µL
* Symptomatic cholelithiasis
* Non-measurable tumor
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Other Identifiers
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CSMS995BFR04
Identifier Type: -
Identifier Source: org_study_id
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