Status:
COMPLETED
Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
Bayer
Chulalongkorn University
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to evaluate the efficacy and safety of Sorafenib in combination with Gemcitabine in patients with advanced/unresectable HCC.
Detailed Description
Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the fifth most common cancer in the world. It is responsible for about 90 percent of the primary malignant liver tumors observed ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00703365
Start Date
February 1 2008
End Date
August 1 2011
Last Update
August 29 2011
Active Locations (3)
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1
Department of Medicine, Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
2
Medical Oncology Unit, Chulalongkorn Hospital
Patumwan, Bangkok, Thailand, 10330
3
Horizon Regional Cancer Center, Bamrungrad Hospital
Sukhumvit, Bangkok, Thailand, 10110