Clinical trial · Interventional
Metformin Plus Sorafenib for Advanced HCC
Safety and Efficacy of Metformin Plus Sorafenib as First-line Therapy in Patients With Advanced Hepatocellular Carcinoma(BCLC-C): A Phase 2 Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sorafenib and Metformin
- description
- Sorafenib 400μg tablet by mouth and Metformin 500mg tablet by mouth with meal, twice per day
- interventionNames
- Drug: Sorafenib
- Drug: Metformin
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib Alone
- description
- Sorafenib 400μg tablet by mouth, twice per day
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 12 months or time to death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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