Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC)

What Was Tested

The trial (phase 2) is built around Leuprolide.

It had three arms (groups): Arm A everolimus (experimental), Arm B letrozole plus leuprolide (experimental) and Arm C combination everolimus, letrozole and leuprolide (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 28 actual participants took part.

It was open to people of any sex aged from 12 years with no upper age limit.

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

Examples of who could join: Patients ≥ 12 years old. Adequate hematologic, renal and hepatic function defined as:. At least 1 target lesion measurable by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines. Prior systemic therapy is allowed. Prior surgery, locoregional ablative or embolic therapies are also permitted provided that the criteria for measurable disease as outlined above are met. Concurrent antiviral therapy for hepatitis B is permitted.

The full record lists 13 inclusion and 17 exclusion criteria; among the exclusions: patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. topical or inhaled corticosteroids are allowed; concurrent oral contraceptive use or hormonal replacement therapy; any investigational drug received within one month of study enrollment.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Leuprolide and the comparison in turn, acting as their own control.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2012-07-12 with completion listed for 2021-07-16.

It ran at 6 sites in United States (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Median PFS, Median Overall Survival (OS), Percentage of Participants With Stable Disease, Number of Participants With One or More Adverse Events/Toxicity and Number of Participants With Tissue Biomarkers Collected.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 28 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.