ISP-TACE Versus TACE for HCC With PVTT

Completed

• Conditions: HCC; Portal Vein Tumor Thrombosis
• Interventions: Drug: ethiodized oil; doxorubicin;Gelfoam; Device: stent; idoine-125

• Registration Number: NCT03108248
• Lead Sponsor: Zhongda Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2016-12-12
• Study Completion: 2017-03-25
• Status Verified: 2017-04
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Study First Posted: 2017-04-11
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TACE group	ethiodized oil; doxorubicin;Gelfoam;	During the study period, a total of 82 patients with HCC with PVTT underwent TACE monotherapy were included in the ISP-TACE group.
TACE group	stent; idoine-125	During the study period, a total of 82 patients with HCC with PVTT underwent TACE monotherapy were included in the ISP-TACE group.
ISP-TACE group	ethiodized oil; doxorubicin;Gelfoam;	During the study period, a total of 44 patients with HCC with PVTT underwent the irradiation stent placement and TACE were included in the ISP-TACE group.

Primary Outcome Measures

Name	Time	Method
survival	0-6 years	The overall survival (OS) was defined as the time from first treatment to death or the patient's last follow up

Trial Locations

Locations (1)

Zhongda Hospital,Southeast University; 🇨🇳 Nanjing, Jiangsu, China