A Randomized, Controlled Phase III Trial of Sorafenib With or Without cTACE in Patients With Advanced HCC
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|ClinicalTrials.gov Identifier: NCT01829035|
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : March 29, 2018
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This is a randomized, multi-center, open-labeled, phase III study in patients with advanced HCC. A total of 338 patients will be randomized (1:1) into one of the two treatment arms, to receive sorafenib with (Arm Combination-treatment; Arm C) or without (Arm Sorafenib alone treatment; Arm S) cTACE.
All the patients will be initially given sorafenib within 72 hours after the randomization. Treatment should continue until the criteria for treatment discontinuation are met.
After the treatment period, patients will undergo follow up for survival every 12 weeks (±7 days) from the last dose, and the survival follow up will be performed for at least 1.5 years after the last patient's last treatment.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Adult Hepatocellular Carcinoma||Other: Conventional Transarterial Chemoembolization (cTACE)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||339 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled Phase III Trial of Sorafenib With or Without Conventional Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma (STAH Study)|
|Actual Study Start Date :||February 21, 2013|
|Actual Primary Completion Date :||June 21, 2017|
|Actual Study Completion Date :||June 21, 2017|
No Intervention: Arm S
sorafenib 400mg bid daily po until progression
Experimental: Arm C
after the first Conventional Transarterial Chemoembolization is completed, sorafenib po and cTACE on demand until progression
Other: Conventional Transarterial Chemoembolization (cTACE)
Concurrent use of the following material/drug is defined as cTACE in this trial.
- The overall survival (OS) of oral sorafenib given as monotherapy daily compared to sorafenib with combination cTACE in subjects [ Time Frame: 3.5 years ]
- Time to progression (TTP)in patients [ Time Frame: 3.5 years ]
- Tumor response rate (TRR)in patients [ Time Frame: 3.5 years ]
- Progression free survival(PFS)will be evaluated [ Time Frame: 3.5 years ]
- Evaluation of adverse events [ Time Frame: 3.5 years ]
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|Ages Eligible for Study:||20 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
To be eligible to participate in the study, patients must meet the following criteria:
- Signed written informed consent
- Clinical or histological diagnosis of HCC based on the guidelines of the Korean Liver Cancer Study Group and the National Cancer Center Korea
- At least one typical enhanced index lesion in the liver that is bi-dimensionally measurable by multiphasic spiral CT scan or dynamic contrast-enhanced MRI, and size of largest tumor is 15 cm or less at enrollment.
- Tumor conditions confirmed by abdominal imaging (contrast enhanced CT ± MRI) and chest imaging (CT) performed within 4 weeks prior to the treatment initiation:
- Age of at least 20 years.
- ECOG Performance Status of 0, 1 or 2.
- Child-Pugh class A or B (Child-Pugh score ≤ 7).
- Life expectancy of at least 16 weeks.
- Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements (no transfusion, no restoration), conducted within 14 days prior to screening:
- Female patients at least 1 year postmenopausal, surgically sterile or those of childbearing potential must have a negative urine pregnancy test within 14 days prior to the first treatment, and have to use at least one medically acceptable and effective contraceptive method for the last 2 months prior to Screening Visit: methods of effective contraception result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as a barrier method (implant, injectable contraceptives, oral contraceptives, intrauterine contraceptive device), hormonal IUD, sexual abstinence or vasectomized partner.
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): NCT01829035
|Korea, Republic of|
|National Cancer Center, Korea|
|Seoul, Korea, Republic of|
|Principal Investigator:||Joong-Won Parkr, Ph.D.||National Cancer Center, Korea|
|Responsible Party:||Joong-Won Park, Chief of Hepatology, Center for Liver Cancer, National Cancer Center, Korea|
|Other Study ID Numbers:||
STAH Korea Trial
|First Posted:||April 11, 2013 Key Record Dates|
|Last Update Posted:||March 29, 2018|
|Last Verified:||March 2018|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases