Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-21

Study Completion Date

2021-03-13

Brief Summary

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Target therapy with sorafenib is the standard of treatment for advanced Hepatocellular carcinoma (HCC), but the patient survival time is still unsatisfactory. The aims of this study are to prove statins improve the tumor responses and overall survival for patients who receive sorafenib therapy for advanced HCC by a prospective randomized controlled study.

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Detailed Description

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Background:

Hepatocellular carcinoma (HCC) is the second leading cause of cancer death worldwide, including the condition in Taiwan, and the management of HCC is an important challenge in public health. Target therapy with sorafenib is the standard of treatment for advanced HCC (vascular invasion or extrahepatic metastasis), but the patient survival time is still unsatisfactory. In recent years, growing evidences, including mechanism analysis, have suggested the anitneoplastic effects of statin, and a recent pooled analysis found that statin use may be associated with improved survival in patients with metastatic rencal cell carcinoma. However, a prospective clinical trial of statin sorafenib combination therapy in the treatment of advanced HCC is lacking.

Aims:

1. To prove statins improve the overall survival for patients who receive sorafenib therapy for advanced HCC by a prospective randomized controlled study.
2. To prove statin can improve tumor responses and the progression free survival for patients who receive sorafenib therapy for advanced HCC by a prospective randomized controlled study.

Methods:

This randomized placebo-controlled study will prospectively enroll patients who receiving sorafenib therapy for advanced HCC in the Taichung Veterans General Hospital, and statin or placebo will be statin or placebo will be administered according to randomized allocations. Tumor responses, time to tumor progression, and survival time will be followed and recorded

Conditions

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Overall Survival Tumor Responses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Statin treated group

Group Type EXPERIMENTAL

Atorvastatin 10mg

Intervention Type DRUG

Atorvastatin or placebo will be administered according to randomized allocations.

Control group

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Atorvastatin or placebo will be administered according to randomized allocations.

Interventions

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Atorvastatin 10mg

Atorvastatin or placebo will be administered according to randomized allocations.

Intervention Type DRUG

Placebo Oral Tablet

Atorvastatin or placebo will be administered according to randomized allocations.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients more than 40 years old
2. HCCs diagnosed by AASLD image criteria or pathology
3. HCCs in BCLC advanced stage, with portal vein thrombosis (VP3 or VP4) or extrahepatic metastasis
4. Not suitable or failed to locoreginal treatments for HCC
5. Child-Pugh score = or \< 6
6. ECOG performance status (PST) 0-2
7. Serum bilirubin \< 2 mg/dL and prothrombin time (PT) prolongation \< 3 seconds
8. Will receive sorafenib therapy
9. Life expectancy \> 3 months
10. Will follow the pregnancy prevention protocol

Exclusion Criteria

1. HCC is considered for curative therapy
2. HCC with brain metastasis
3. History of systemic therapy for HCC
4. Indications for statin use, such as hyperlipidemia in cardiovascular diseases
5. Any local treatment for HCC within 4 weeks
6. Any active gastrointestinal bleeding within 4 weeks
7. Liver transplant history or concomitant immunosuppressive therapy
8. Concurrent any other malignancy
9. Allergy to sorafenib or statins
10. Pregnancy or lactation
11. Serum AST or ALT \> 5x upper limit of normal
12. Known HIV infection
13. eGFR \< 30 ml/min
14. Abnormal medical conditions that are unsuitable for study, such as uncontrolled hypertension, coronary arterial disease, or arrhythmia

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No