NCT03910140

TILA-TACE in Treatment of Hepatocellular Carcinoma

A Prospective Non-controlled Single-arm Study of TILA-TACE in Treatment of Hepatocellular Carcinoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To validate the tumor response rate: in the previous study, the investigators showed that TILA-TACE achieved 100% tumor response rate. However, as the study sample size was 40, the investigators need to validate the tumor response rate using a larger sample size; To validate the overall survival: in the previous study, the investigators showed that TILA-TACE significantly prolonged the overall survival of the patients with large and massive tumor. Again, the sample size was small, the investigators need to validate the data using a large sample size.

Conditions

• Tumor Response Rate
• Overall Survival

Interventions

Type	Name	Description
PROCEDURE	TILA-TACE treatment	TACE was performed through the transfemoral route using a 5-Fr catheter (Shepherd-hook modified Angiographic Catheter, HANACO Medical, Tian Jin, China ) that was advanced from celiac artery to common hepatic artery, proper hepatic artery, hepatic artery and ultimately to tumor feeding arteries which are defined by angiography. Then, a coaxial microcatheter (2.8 Fr Marguerite II, ASAHI INTECC GMA CO., LTD, Nagoya, Japan) was selectively inserted through a 5-Fr catheter into the tumor feeding artery, into which, 5% sodium bicarbonate was infused alternatively with doxorubicin-lipiodol emulsion. Finally, the artery was embolized with PVA (Embosphere®, BioSphere Medical, Paris, France) and microcoil ( Tornado ®, COOK Medical, USA).

Timeline

• Start date: 2017-11-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-04-10
• Last updated: 2019-04-10

Locations

1 site across 1 country: China