Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT01556815|
Recruitment Status : Unknown
Verified April 2012 by Jinlong Song, Shandong Cancer Hospital and Institute.
Recruitment status was: Not yet recruiting
First Posted : March 16, 2012
Last Update Posted : April 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|PHENYTOIN/SORAFENIB [VA Drug Interaction] Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction] HBV||Procedure: Transarterial Chemoembolization (TACE) Other: Sorafenib in combination with TACE||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||May 2015|
Active Comparator: Group TACE
Patients who undergo TACE
Procedure: Transarterial Chemoembolization (TACE)
Procedure:TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .
Experimental: Group Combination
Patients who are treated with sorafenib combined with TACE
Other: Sorafenib in combination with TACE
Drug: Sorafenib All patients will receive Sorafenib (800 mg/day) p.o. beginning one week after the first TACE and every day thereafter until patient death or premature withdrawal from study.
TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .
Other Name: Sorafenib:Nexavar(brand name)
- Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE) [ Time Frame: 1 year ]Measure:time-to-proression
- safety of sorafenib in combination with TACE [ Time Frame: 6 months ]Measure: incidence and grade of adverse events in patients treated with sorafenib combined with TACE (group B)
- Survival in the two treatment groups [ Time Frame: 2 years ]Measured from the date of TACE until the date of death or last visit
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): NCT01556815
|Contact: Jinlong Song, MDfirstname.lastname@example.org|
|Shandong Cancer Hospital and Institute||Not yet recruiting|
|Jinan, Shandong, China, 250117|
|Contact: Wenbo Shao, MD, Ph D +8653167626412 email@example.com|
|Principal Investigator: Jinlong Song, MD|
|Sub-Investigator: Wenbo Shao, MD, Ph D|
|Principal Investigator:||Jinlong Song, MD||Shandong Cancer Hospital and Institute|