NCT00241020

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2002

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

3.3 years

First QC Date

October 14, 2005

Last Update Submit

April 11, 2016

Conditions

Advanced Hepatocellular Carcinoma

Keywords

hepatocellular carcinomaOctreotide

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

Secondary Outcomes (6)

  • Objective response

  • Survival without progression

  • Digestive bleeding

  • Renal insufficiency

  • Quality of life

  • +1 more secondary outcomes

Study Arms (1)

Octreotide

EXPERIMENTAL
Drug: Octreotide

Interventions

OctreotideDRUG
Octreotide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Octreotide

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

June 1, 2002

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

April 12, 2016

Record last verified: 2016-04