Overview

Metformin Plus Sorafenib for Advanced HCC

Status:
Unknown status

Trial end date:
2018-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Tianjin Medical University Cancer Institute and Hospital

Collaborators:

First Affiliated Hospital of Harbin Medical University
Fudan University
Harbin Medical University
Liaoning Tumor Hospital & Institute
Shanghai Zhongshan Hospital

Treatments:

Metformin
Niacinamide
Sorafenib

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