Overview

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