Back to resultsA Randomized, Controlled Phase III Trial of Sorafenib With or Without cTACE in Patients With Advanced HCC
Primary Purpose
Advanced Adult Hepatocellular Carcinoma
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Conventional Transarterial Chemoembolization (cTACE)
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Adult Hepatocellular Carcinoma focused on measuring TACE, Sorafenib
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Sites / Locations
- National Cancer Center, Korea
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Arm S
Arm C
Arm Description
sorafenib 400mg bid daily po until progression
after the first Conventional Transarterial Chemoembolization is completed, sorafenib po and cTACE on demand until progression
Outcomes
Primary Outcome Measures
The overall survival (OS) of oral sorafenib given as monotherapy daily compared to sorafenib with combination cTACE in subjects
Secondary Outcome Measures
Time to progression (TTP)in patients
Tumor response rate (TRR)in patients
Progression free survival(PFS)will be evaluated
Evaluation of adverse events
Full Information
NCT ID
NCT01829035
First Posted
March 31, 2013
Last Updated
March 27, 2018
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT01829035
Brief Title
A Randomized, Controlled Phase III Trial of Sorafenib With or Without cTACE in Patients With Advanced HCC
Official Title
A Randomized, Controlled Phase III Trial of Sorafenib With or Without Conventional Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma (STAH Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 21, 2013 (Actual)
Primary Completion Date
June 21, 2017 (Actual)
Study Completion Date
June 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Adult Hepatocellular Carcinoma
Keywords
TACE, Sorafenib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
339 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm S
Arm Type
No Intervention
Arm Description
sorafenib 400mg bid daily po until progression
Arm Title
Arm C
Arm Type
Experimental
Arm Description
after the first Conventional Transarterial Chemoembolization is completed, sorafenib po and cTACE on demand until progression
Intervention Type
Other
Intervention Name(s)
Conventional Transarterial Chemoembolization (cTACE)
Intervention Description
Concurrent use of the following material/drug is defined as cTACE in this trial.
Embolization material (e.g., gelatin sponges, porous gelatin particles, Ivalon, etc.) other than ethiodized oil
Anti-tumor drug:
Unapproved drug/embolization material from each regulatory agency should not be used.
To chemo-embolize all arteries feeding viable lesions via super selective cTACE, which is more effective and can be recommended as it rarely causes impairment of non-cancerous liver tissues. After assessing the disappearance of tumor stain as much as possible by angiography, the cTACE procedure should be completed
Primary Outcome Measure Information:
Title
The overall survival (OS) of oral sorafenib given as monotherapy daily compared to sorafenib with combination cTACE in subjects
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
Time to progression (TTP)in patients
Time Frame
3.5 years
Title
Tumor response rate (TRR)in patients
Time Frame
3.5 years
Title
Progression free survival(PFS)will be evaluated
Time Frame
3.5 years
Title
Evaluation of adverse events
Time Frame
3.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joong-Won Parkr, Ph.D.
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center, Korea
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
30529387
Citation
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.
Results Reference
derived
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A Randomized, Controlled Phase III Trial of Sorafenib With or Without cTACE in Patients With Advanced HCC
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