GH, IGF-I and Somatostatin Analogues in Hepatocellular Carcinoma

What Was Tested

This registered phase 2, phase 3 trial tested Octreotide and Lanreotide.

In Campania region, mortality for HCC is 2 times higher than in the rest of Italy because of a higher locally prevalence of hepatitis-C virus infection.

It had two arms (groups): A (experimental) and B (other).

Historical controls.

The registry classes the interventions as drug and other.

More on the Plan

To evaluate relationships between GH/IGF-I and IGF-II axis and development and progression of HCC; 2.

To evaluate the expression of somatostatin receptor expression in biopsies of HCC by quantitative RT-PCR and immunohistochemistry and in vivo by octreoscan; 3.

To correlate the response to somatostatin analogues to somatostatin receptor expression in vitro and in vivo and suppression of the IGF-I and -II axis.

Study protocol All enrolled subjects will be subjects to a baseline evaluation and a post-treatment evaluation according with the treatment protocol (see below).

Who Took Part

The registry lists 25 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: age \< 18 yrs or \> 75 yrs; pregnancy or lactation; intolerance to somatostatin analogues.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-04 with completion listed for 2008-04.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Prolongation of the survival curve (>6 months) (time frame: 12 months).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, non-randomized trial of Octreotide and Lanreotide in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page and the Lanreotide compound page, all human trials.