Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Advanced Hepatocellular Carcinoma (HCC)

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the efficacy and safety of Sorafenib in combination with Gemcitabine in patients with advanced/unresectable HCC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Collaborators: Bayer; Bumrungrad International Hospital; Chulalongkorn University
• Treatments: Gemcitabine; Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• patient at least 18 years of age with written informed consent prior to enrollment into the study.

• histologically or cytologically confirmed advanced unresectable and/or metastasis) HCC

• Child-Pugh class A or B

• Have measurable disease according to RECIST criteria

• life expectancy of at least 12 weeks, ECOG 0-2

• Have adequate bone marrow reserve and liver and renal function at screening

• Practice adequate contraception during study participation

Exclusion Criteria:

• Exclude medical conditions including history of cardiac disease, HIV infection,active infection,brain metastastasis or intracranial metastasis,seizure disorder requiring medication, history of organ allograft,evidence of or history of bleeding diathesis,previous or concurrent cancer with distinct in primary site or histology (with exception of cervical carcinoma in situ and treated basal cell carcinoma

• Excluded therapies and medications, previous and concomitant : prior systemic anticancer chemotherapy or immunotherapy or targeted therapy,hormonal therapy within 2 weeks,local treatment modality within 4 weeks,radiotherapy within 3 weeks,major surgery and unhealed wound within 4 weeks,autologous bone marrow transplant or stem cell rescue within 4 months

• other condition that may interfere with the patient's participation in the study or evaluation of the results