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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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ClinicalTrials.gov Identifier: NCT01829035
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Joong-Won Park, National Cancer Center, Korea

Study Description
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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.


Condition or disease Intervention/treatment Phase
Advanced Adult Hepatocellular Carcinoma Other: Conventional Transarterial Chemoembolization (cTACE) Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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Arm Intervention/treatment
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.

  • Embolization material (e.g., gelatin sponges, porous gelatin particles, Ivalon, etc.) other than ethiodized oil

  • Anti-tumor drug:

    1. Unapproved drug/embolization material from each regulatory agency should not be used.
    2. 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Time to progression (TTP)in patients [ Time Frame: 3.5 years ]
  2. Tumor response rate (TRR)in patients [ Time Frame: 3.5 years ]
  3. Progression free survival(PFS)will be evaluated [ Time Frame: 3.5 years ]
  4. Evaluation of adverse events [ Time Frame: 3.5 years ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible to participate in the study, patients must meet the following criteria:

  1. Signed written informed consent
  2. Clinical or histological diagnosis of HCC based on the guidelines of the Korean Liver Cancer Study Group and the National Cancer Center Korea
  3. 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.
  4. Tumor conditions confirmed by abdominal imaging (contrast enhanced CT ± MRI) and chest imaging (CT) performed within 4 weeks prior to the treatment initiation:
  5. Age of at least 20 years.
  6. ECOG Performance Status of 0, 1 or 2.
  7. Child-Pugh class A or B (Child-Pugh score ≤ 7).
  8. Life expectancy of at least 16 weeks.
  9. 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:
  10. 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:

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Korea, Republic of
National Cancer Center, Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
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Principal Investigator: Joong-Won Parkr, Ph.D. National Cancer Center, Korea
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joong-Won Park, Chief of Hepatology, Center for Liver Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01829035    
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
Keywords provided by Joong-Won Park, National Cancer Center, Korea:
TACE
Sorafenib
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases