A Randomized, Controlled Phase III Trial of Sorafenib With or Without cTACE in Patients With Advanced HCC

NCT ID: NCT01829035

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-21
• Study Completion Date: 2017-06-21

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).

Conditions

Advanced Adult Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm S

sorafenib 400mg bid daily po until progression

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm C

after the first Conventional Transarterial Chemoembolization is completed, sorafenib po and cTACE on demand until progression

Group Type: EXPERIMENTAL

Conventional Transarterial Chemoembolization (cTACE)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Joong-Won Park

Chief of Hepatology, Center for Liver Cancer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joong-Won Parkr, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center, Korea

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30529387 (View on PubMed)

Other Identifiers

STAH Korea Trial

Identifier Type: -

Identifier Source: org_study_id