ISP-TACE Versus TACE for HCC With PVTT

HCC Clinical Trial

Official title:

Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: Survival Benefit of Transarterial Chemoembolization in Combination With Irradiation Stent Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108248
• Other study ID #: ZhongdaHP
• Status: Completed
• Phase: N/A
• First received: April 4, 2017
• Last updated: April 4, 2017
• Start date: January 1, 2011
• Est. completion date: March 25, 2017

Study information

• Verified date: April 2017
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This study aimed to investigate whether TACE in combination with irradiation stent placement (ISP) could prolong the survival in patients with HCC and PVTT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: March 25, 2017
• Est. primary completion date: December 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• (1) newly diagnosed HCC with type II or III PVTT, (2) Child-Pugh classification grade A or B, (3) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.

Exclusion Criteria:

• (1) type I or IV PVTT, (2) received sorafenib, systemic chemotherapy, or external radiotherapy during the treatment, (3) suffered from malignancy other than HCC, (4) with an incomplete data.

Related Conditions & MeSH terms

• HCC
• Portal Vein Tumor Thrombosis
• Thrombosis

Intervention

Drug:
• ethiodized oil; doxorubicin;Gelfoam;
Conventional TACE was performed in both groups as follows. First, multiple angiographies were performed to detect the hepatic arterial anatomy and the possible feeding arteries of tumor, selective catheterization of the artery feeding the tumors was performed. A mixture of ethiodized oil was injected, followed by injection of Gelfoam particles.

Device:
• stent; idoine-125
In the ISP-TACE group, stent placement was performed one week before TACE. Under fluoroscopic and ultrasonic guidance, the outer stent was firstly placed at the site of the obstructed portal vein, and a self-expandable nitinol stent was immediately followed through a same 10-F sheath.

Locations

Country	Name	City	State
China	Zhongda Hospital,Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	The overall survival (OS) was defined as the time from first treatment to death or the patient's last follow up	0-6 years