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

What Was Tested

The trial (phase 3) is built around Octreotide and Somatostatin.

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.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 108 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: 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.

The full record lists 3 inclusion and 18 exclusion criteria; among the exclusions: patient with symptomatic cholecyst-/choledocholithiasis; patient with severe psychiatric disease; participation in another clinical trial within the last 4 weeks.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

It started in 1999-10 with completion listed for 2003-02.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Overall survival time.

It also tracked 6 secondary outcomes, for example Costs of the treatment measured by days of in-patient treatment, Side effects, Patient compliance, Quality of life, Somatostatin receptors in the tumor tissue and Prognostic relevance of the Somatostatin receptors.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide and Somatostatin in 108 people.

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 Somatostatin compound page, all human trials.