Neoplasms

Digestive System Diseases

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Carcinoma, Hepatocellular

Carcinoma

Adenocarcinoma

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Gastrointestinal Diseases

Liver Diseases

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Pravastatin

Sorafenib

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Enzyme Inhibitors

The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.

The treatment received will be sorafenib 400 mg/12 h + placebo/24 h.

Treatment:

Patients will be randomized in two groups, A and B:

* Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h.
* Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.

Juan I Arenas, MD,PHD

Javier Bustamante Scheneider, MD

Trinidad Serrano Aullo, MD, PHD

Mercedes Iñarrairaegui Bastarrica, MD

Sonia Blanco Sampascual, MD

Maria Varela, MD, PHD

Oscar Nuñez, MD

The purpose of this study is to evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.

Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma

Phase-II, Multicenter, Randomized, Double-Blind, Parallel-Group Trial to Compare the Efficacy and Safety of Sorafenib Plus Pravastatin Against Sorafenib Plus Placebo in Patients With Advanced Hepatocarcinoma

To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma	NCT01418729	Advanced Hepato...	Pravastatin	18 Years - 100 Years	Hospital Donostia
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma	NCT01418729	Advanced Hepato...	Pravastatin	18 Years - 100 Years	Hospital Donostia
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma	NCT01418729	Advanced Hepato...	Pravastatin	18 Years - 100 Years	Hospital Donostia

Spots Global Cancer Trial Database for advanced hepatocarcinoma