Transarterial Chemoembolization (TACE) With Radiation Therapy (RT) in Advanced Hepatocellular Carcinoma (HCC)
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|ClinicalTrials.gov Identifier: NCT02290977|
Recruitment Status : Unknown
Verified December 2014 by Paik Yong Han, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : November 14, 2014
Last Update Posted : December 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Portal Vein Tumor Thrombosis||Radiation: Scheduled interval TACE - RT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Scheduled Interval Trans-catheter Arterial Chemo-embolization and Radiation Therapy for Hepatocellular Carcinoma Combined With Portal Vein Tumor Thrombosis: Prospective Phase II Trial|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||April 2016|
Experimental: Scheduled TACE-RT
RT will be delivered at two weeks after TACE for HCC combined PVTT.
Radiation: Scheduled interval TACE - RT
RT will be administered at 2 weeks after TACE in HCC combined PVTT
- Overall survival rate after scheduled TACE-RT for HCC with PVTT [ Time Frame: One year after treatment ]Overall survival rate will be evaluated at 1 year after treatment.
- Adverse event assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 after scheduled TACE-RT for HCC with PVTT [ Time Frame: Three months after treatment ]Adverse event will be evaluated at 3 months after treatment.
- Radiologic response assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST) after scheduled TACE-RT for HCC with PVTT [ Time Frame: Three months after treatment ]Radiologic response will be evaluated at 3 months 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): NCT02290977
|Contact: Yong Han Paik, Professorfirstname.lastname@example.org|
|Contact: Ju Yeon Cho, MDemail@example.com|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Yong Han Paik, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Yong-Han Paik, MD, PhD|
|Sub-Investigator: Hee Chul Park, MD, PhD|
|Sub-Investigator: Ju-Yeon Cho, MD|
|Sub-Investigator: Jeong Il Yu, MD|