Hector-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma

Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00386984

Enrollment

108

Registered

2006-10-12

Start date

1999-10-31

Completion date

2003-02-28

Last updated

2006-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

Keywords

hepatocellular carcinoma; Sandostatin-LAR; RCT

Brief summary

A preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can prolong survival time in patients with primary liver cancer. Due to methodological deficiencies of the preliminary study the results will be re-checked by the comparison of octreotide with an pseudo-drug (so-called placebo) primarily regarding to the survival time and secondarily concerning costs, side effects, patient cooperation and quality of life as well as specific conditions in the tumor tissue in both groups with 108 patients with primary liver cancer.

Detailed description

A pilot study showed that octreotide can prolong survival time of patients with HCC. Due to methodological deficiencies the results of this pilot study will be re-evaluated by comparison of octreotide versus placebo primarily regarding to the global survival time and secondarily concerning the costs, side effects, patient compliance and quality of life as well as the Somatostatin receptors in the tumor tissue and its prognostic relevance in both groups with 108 patients with hepatocellular carcinoma. An interim analysis was done after occurrence of the half of the events (deaths). No significant effect could be shown.

Interventions

DRUGSomatostatin (octreotide)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Inoperable patients * histologically confirmed HCC or patients who refuse surgery and who otherwise (e.g. due to the advanced tumor stage) are not applicable for palliative local therapy (e.g. PEI, TACE, RFTA). * Age: 18 years or older

Exclusion criteria

General: * Patient with symptomatic Cholecyst-/Choledocholithiasis * Patient with severe psychiatric disease. * Participation in another clinical trial within the last 4 weeks. * Simultaneous participation in another clinical examination. * Legally incapacitated patient, who is not able, to understand nature, meaning and consequence of the study. * Continuous drug or alcohol abuse. * Patient with known HIV infection and antiretroviral therapy. * Patient with not controllable infection disease. * Pregnancy. Study- and indication-specific

Design outcomes

Primary

Measure	Time frame
Overall survival time	—

Secondary

Measure	Time frame
Side effects	—
Patient compliance	—
Costs of the treatment measured by days of in-patient treatment	—
Somatostatin receptors in the tumor tissue	—
Prognostic relevance of the Somatostatin receptors	—
Quality of life	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026