NCT01829035

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

A Randomized, Controlled Phase III Trial of Sorafenib With or Without Conventional Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma (STAH Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 339 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-02-21
• Primary completion: 2017-06-21
• Completion: 2017-06-21
• First posted: 2013-04-11
• Last updated: 2018-03-29

Locations

1 site across 1 country: South Korea