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ISP-TACE Versus TACE for HCC With PVTT

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03108248
Enrollment
126
Registered
2017-04-11
Start date
2011-01-01
Completion date
2017-03-25
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC, Portal Vein Tumor Thrombosis

Keywords

transarterial chemoembolization, stent, irradiation, survival, decompensation, tumor response

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.

Interventions

DRUGethiodized 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.

DEVICEstent; 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.

Sponsors

Zhongda Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
survival0-6 yearsThe overall survival (OS) was defined as the time from first treatment to death or the patient's last follow up

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026