Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma

Sponsor
Taichung Veterans General Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03275376
Collaborator
(none)
34
1
2
38.7
0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Atorvastatin 10mg
  • Drug: Placebo Oral Tablet
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma: A Randomized Controlled Study
Actual Study Start Date :
Dec 21, 2017
Actual Primary Completion Date :
Dec 21, 2020
Actual Study Completion Date :
Mar 13, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Statin treated group

Drug: Atorvastatin 10mg
Atorvastatin or placebo will be administered according to randomized allocations.

Placebo Comparator: Control group

Drug: Placebo Oral Tablet
Atorvastatin or placebo will be administered according to randomized allocations.

Outcome Measures

Primary Outcome Measures

  1. Overall survival [Three year]

Secondary Outcome Measures

  1. Best tumor response [Three year]

  2. Progression free survival [Three year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taichung Veterans General Hospital Taichung Taiwan 40705

Sponsors and Collaborators

  • Taichung Veterans General Hospital

Investigators

  • Principal Investigator: Teng-Yu Lee, MD, Taichung Veterans General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Teng-Yu Lee, MD, PhD, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT03275376
Other Study ID Numbers:
  • CF16263B
First Posted:
Sep 7, 2017
Last Update Posted:
Mar 16, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2021