Study Results
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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UNKNOWN
PHASE2
82 participants
INTERVENTIONAL
2015-12-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sorafenib and Metformin
Sorafenib 400μg tablet by mouth and Metformin 500mg tablet by mouth with meal, twice per day
Sorafenib
Standard treatment for advanced HCC
Metformin
To evaluate the safety and efficacy of the combined treatment of Metformin and Sorafenib for advanced HCC
Sorafenib Alone
Sorafenib 400μg tablet by mouth, twice per day
Sorafenib
Standard treatment for advanced HCC
Interventions
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Sorafenib
Standard treatment for advanced HCC
Metformin
To evaluate the safety and efficacy of the combined treatment of Metformin and Sorafenib for advanced HCC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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First Affiliated Hospital of Harbin Medical University
OTHER
Harbin Medical University
OTHER
Liaoning Cancer Hospital & Institute
OTHER
Shanghai Zhongshan Hospital
OTHER
Fudan University
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Ti Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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METSOR
Identifier Type: -
Identifier Source: org_study_id
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