NCT02290977

Transarterial Chemoembolization (TACE) With Radiation Therapy (RT) in Advanced Hepatocellular Carcinoma (HCC)

Scheduled Interval Trans-catheter Arterial Chemo-embolization and Radiation Therapy for Hepatocellular Carcinoma Combined With Portal Vein Tumor Thrombosis: Prospective Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The presence of portal vein tumor thrombosis (PVTT) in patients with hepatocellular carcinoma (HCC) is one of the most significant prognostic factors for poor prognosis, without treatment, their survival is less than 3 months. In the HCC patients who combined with PVTT, Radiation therapy (RT) showed 50% of local control and about 10 months survival duration. Despite the standard treatment of the HCC combined with PVTT is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an alternative option in those patients. Investigators previously reported the retrospective study that the scheduled interval Trans-catheter Arterial Chemo-embolization (TACE) followed by RT for HCC combined with PVTT and 60% of the patients showed objective response without significant elevation of complication. However, the prospective outcomes of TACE followed by RT for HCC are scantly reported. Based on those background, we start this prospective study to evaluate the clinical outcomes and adverse event in the RT after TACE in the unresectable HCC patients who combined with PVTT.

Conditions

• Hepatocellular Carcinoma
• Portal Vein Tumor Thrombosis

Interventions

Type	Name	Description
RADIATION	Scheduled interval TACE - RT	RT will be administered at 2 weeks after TACE in HCC combined PVTT

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-10-01
• Completion: 2016-04-01
• First posted: 2014-11-14
• Last updated: 2014-12-05

Locations

1 site across 1 country: South Korea