NCT02630108

TACE Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma

Clinical Study of Transarterial Chemoembolization (TACE) Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer.

Detailed description

It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Jian-Hua Wang. Investigators in twenty-five hospitals in China participate in. Patients with unresectable large HCC (\>5cm in diameter) and huge HCC (\>=10cm in diameter) are enrolled. The investigators propose to recruitment 280 patients who are randomly assigned into the combined group (treated with TACE and synchronous ablation) and the control group (treated with TACE alone) according to the proportion of 1:1, which means 140 patients in each group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
PROCEDURE	Thermal Ablation	Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.
DRUG	EADM	EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
DRUG	Ultra-fluid lipiodol	Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
OTHER	Gelatin sponge articles	Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-01
• Completion: 2018-04-01
• First posted: 2015-12-15
• Last updated: 2016-10-18

Locations

1 site across 1 country: China