Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01214343|
Recruitment Status : Unknown
Verified October 2010 by Ministry of Health, Labour and Welfare, Japan.
Recruitment status was: Recruiting
First Posted : October 5, 2010
Last Update Posted : June 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Advanced Hepatocellular Carcinoma Carcinoma Carcinoma, Hepatocellular Liver Neoplasms Neoplasms||Drug: Sorafenib with Low-dose FP Drug: Sorafenib||Phase 3|
Sorafenib with Low-dose FP Group
Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days. Cisplatin at the dose of 20mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330mg/m2 will be administered continuously at day1-day5, and day8-day12 via the implanted catheter system.
Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days.
The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial Comparing Efficacy of Sorafenib Versus Sorafenib In Combination With Low Dose Cisplatin /Fluorouracil Hepatic Arterial InfUSion Chemotherapy in Patients With Advanced Hepatocellular Carcinoma|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
|Experimental: Sorafenib with Low-dose FP||
Drug: Sorafenib with Low-dose FP
Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in a cycle. Cisplatin at the dose of 20 mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330 mg/m2 will be administered continuously at day 1-day 5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days.
|Active Comparator: Sorafenib||
Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in each cycle.A cycle is defined as 28 days.
Other Name: Nexavar
- Overall survival [ Time Frame: Overall survival is defined as the time from randomization to death due to any cause ]
- Time to progression [ Time Frame: TTP is defined as the time from randomization to radiological progression. ]
- Progression Free Survival [ Time Frame: PFS is defined as the time from randomization to radiological progression or death due to any cause ]
- Change of tumor marker [ Time Frame: Every 4-6 weeks ]
- Biomarker predicting the efficacy [ Time Frame: Pre and after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214343
|Contact: Masatoshi Kudo, Professor||+81-72-366-0221 ext email@example.com|
|Contact: Kazuomi Ueshima, Dr||+81-72-366-0221 ext firstname.lastname@example.org|
|Study Chair:||Masatoshi Kudo, Professor||Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology|