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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

Tracking Information
First Submitted Date  ICMJE December 7, 2015
First Posted Date  ICMJE February 3, 2016
Last Update Posted Date February 3, 2016
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
Overall Survival [ Time Frame: 12 months or time to death ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • Time To Progression [ Time Frame: 12 months or time to death ]
  • Progression Free Survival [ Time Frame: 12 months ]
  • Objective Response Rate [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metformin Plus Sorafenib for Advanced HCC
Official Title  ICMJE Safety and Efficacy of Metformin Plus Sorafenib as First-line Therapy in Patients With Advanced Hepatocellular Carcinoma(BCLC-C): A Phase 2 Randomized Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Sorafenib and Metformin
    Sorafenib 400μg tablet by mouth and Metformin 500mg tablet by mouth with meal, twice per day
    Interventions:
    • Drug: Sorafenib
    • Drug: Metformin
  • Active Comparator: Sorafenib Alone
    Sorafenib 400μg tablet by mouth, twice per day
    Intervention: Drug: Sorafenib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 2, 2016)
82
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02672488
Other Study ID Numbers  ICMJE METSOR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Tianjin Medical University Cancer Institute and Hospital
Study Sponsor  ICMJE Tianjin Medical University Cancer Institute and Hospital
Collaborators  ICMJE
  • First Affiliated Hospital of Harbin Medical University
  • Harbin Medical University
  • Liaoning Tumor Hospital & Institute
  • Shanghai Zhongshan Hospital
  • Fudan University
Investigators  ICMJE
Principal Investigator: Ti Zhang, MD Tianjin Medical University Cancer Institute and Hospital
PRS Account Tianjin Medical University Cancer Institute and Hospital
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP