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Metformin Plus Sorafenib for Advanced HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672488
Recruitment Status : Unknown
Verified December 2015 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborators:
First Affiliated Hospital of Harbin Medical University
Harbin Medical University
Liaoning Tumor Hospital & Institute
Shanghai Zhongshan Hospital
Fudan University
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
Metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got much more attentions recently. It has been shown that metformin exerts anti-cancer activities in several cancers, including primary liver cancer. In this phase II study, safety and efficacy of the combination of metformin and sorafenib will be evaluated in patients with advanced hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Sorafenib Drug: Metformin Phase 2

Detailed Description:
Sorafenib is the standard choice for advanced hepatocellular carcinoma (BCLC-C), but the efficacy is not satisfied. Metformin is a widely used oral drug for type 2 diabetes and its antitumor effects have got much more attentions recently. It has been shown that metformin exerts anti-cancer activities in several cancers, including primary liver cancer. Recent studies suggest that metformin treatment can reduce the risk of HCC in patients with type 2 diabetes and inhibit HCC invasion and increase drug sensitivity to sorafenib, however, the safety and efficacy of combined therapy for advanced hepatocellular carcinoma remains unclear. In this phase II study, patients with advanced hepatocellular carcinoma, measurable disease, and an Eastern Cooperative Oncology Group performance score≤1 will be enrolled. Eligible subjects will be randomly assigned to receive the treatment of sorafenib or metformin plus sorafenib. The potential improvement of overall survival, time to progression and safety will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Metformin Plus Sorafenib as First-line Therapy in Patients With Advanced Hepatocellular Carcinoma(BCLC-C): A Phase 2 Randomized Study
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sorafenib and Metformin
Sorafenib 400μg tablet by mouth and Metformin 500mg tablet by mouth with meal, twice per day
Drug: Sorafenib
Standard treatment for advanced HCC
Other Name: Nexavar

Drug: Metformin
To evaluate the safety and efficacy of the combined treatment of Metformin and Sorafenib for advanced HCC
Other Name: Glucophage

Active Comparator: Sorafenib Alone
Sorafenib 400μg tablet by mouth, twice per day
Drug: Sorafenib
Standard treatment for advanced HCC
Other Name: Nexavar




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 12 months or time to death ]

Secondary Outcome Measures :
  1. Time To Progression [ Time Frame: 12 months or time to death ]
  2. Progression Free Survival [ Time Frame: 12 months ]
  3. Objective Response Rate [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
  2. Confirmed hepatocellular carcinoma according to one of following three criteria:

    histopathology,Two radiographic techniques (US, MRI, CT, or Angiography) that confirm lesion with typical arterial hypervascularization,Barcelona Clinical Liver Cancer staging C (BCLC-C)

  3. Age > 18 years old
  4. Patients with liver disease classified as Child Pugh class A
  5. Eastern Clinical Oncology Group (ECOG) performance status 0,1 or 2 (Appendix I)
  6. Hemoglobin ≥ 9 g/dL
  7. Absolute Neutrophil count(ANC)≥ 1,500 /mm3
  8. Platelet count≥ 50,000 /ul
  9. Total Bilirubin < 2 mg/dL
  10. Transaminases (SGOT and SGPT) no more than 5 times the upper limit of normal
  11. Alkaline phosphatase < 4 times the upper limit of normal
  12. Both men and women and members of all races and ethnic groups are eligible for this study
  13. Prothrombin time > 50% 或 PT-INR < 2.3

Exclusion Criteria:

  1. Child Pugh Score is 7 with ascites
  2. Severe cardiovascular disease
  3. Uncontrollable hypertension
  4. History of HIV infection
  5. Active clinical severe infection(>grade 2 ,NCI-CTCAE Version3.0)
  6. Women who are pregnant
  7. Administration of any systemic chemotherapy within the last 6 months
  8. Presence of History of gastrointestinal bleeding before randomization
  9. Epileptic seizures requiring drug therapy
  10. History of allograft transplantation
  11. Patients with signs of bleeding or medical history
  12. Patients undergoing kidney dialysis
  13. Metastatic liver cancer
  14. Uncontrollable ascites
  15. Encephalopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672488


Contacts
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Contact: Zhao Yan, PhD +862223340123 ext 6012 chengdongyan916@163.com
Contact: Dongyan Cheng, MS +862223359984 chengdongyan916@163.com

Locations
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China
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, China, 300060
Contact: TI ZHANG, MD    +862223340123 ext 3092    zhangti@tjmuch.com   
Contact: Huikai Li, MD    +862223340123 ext 3091    lihuikai@tjmuch.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
First Affiliated Hospital of Harbin Medical University
Harbin Medical University
Liaoning Tumor Hospital & Institute
Shanghai Zhongshan Hospital
Fudan University
Investigators
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Principal Investigator: Ti Zhang, MD Tianjin Medical University Cancer Institute and Hospital
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02672488    
Other Study ID Numbers: METSOR
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Metformin
Sorafenib
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action