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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Tracking Information | ||||
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First Submitted Date ICMJE | March 31, 2013 | |||
First Posted Date ICMJE | April 11, 2013 | |||
Last Update Posted Date | March 29, 2018 | |||
Actual Study Start Date ICMJE | February 21, 2013 | |||
Actual Primary Completion Date | June 21, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The overall survival (OS) of oral sorafenib given as monotherapy daily compared to sorafenib with combination cTACE in subjects [ Time Frame: 3.5 years ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Randomized, Controlled Phase III Trial of Sorafenib With or Without cTACE in Patients With Advanced HCC | |||
Official Title ICMJE | A Randomized, Controlled Phase III Trial of Sorafenib With or Without Conventional Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma (STAH Study) | |||
Brief Summary | 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. |
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Detailed Description | The superiority of the Arm C (cTACE+Sorafenib) over the Arm S (Sorafenib) in the OS period will be verified in the ITT set and FAS using a stratified log-rank test. Stratification factors consist of mUICC stage (III vs. IV), Vascular invasion (none and Vp1-2 vs. Vp3-4 and any other presence), Child-Pugh score (5 vs. 6-7), serum AFP level (≥200 ng/mL vs. <200 ng/mL). The significance level is 5% (one-sided). | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Adult Hepatocellular Carcinoma | |||
Intervention ICMJE | Other: Conventional Transarterial Chemoembolization (cTACE)
Concurrent use of the following material/drug is defined as cTACE in this trial.
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Study Arms ICMJE |
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Publications * | Park JW, Kim YJ, Kim DY, Bae SH, Paik SW, Lee YJ, Kim HY, Lee HC, Han SY, Cheong JY, Kwon OS, Yeon JE, Kim BH, Hwang J. Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial. J Hepatol. 2019 Apr;70(4):684-691. doi: 10.1016/j.jhep.2018.11.029. Epub 2018 Dec 6. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
339 | |||
Original Estimated Enrollment ICMJE |
338 | |||
Actual Study Completion Date ICMJE | June 21, 2017 | |||
Actual Primary Completion Date | June 21, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: To be eligible to participate in the study, patients must meet the following criteria:
Exclusion Criteria: |
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01829035 | |||
Other Study ID Numbers ICMJE | STAH Korea Trial | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Joong-Won Park, National Cancer Center, Korea | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | National Cancer Center, Korea | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Cancer Center, Korea | |||
Verification Date | March 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |