Combination Treatment for Advanced Liver Cancer

Transarterial Chemoembolisation (TACE) Combined With Endovascular Implantation of Bare Stent and Iodine-125 Seed Strand for the Treatment of Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis Versus TACE Alone

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02149771

Enrollment

Registered

2014-05-29

Start date

2014-05-31

Completion date

2016-09-30

Last updated

2018-04-19

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

Conditions

Hepatocellular Carcinoma, Hepatic Portal Vein Tumor Invasion

Keywords

hepatocellular carcinoma, portal vein tumor thrombosis, stents, chemoembolization

Brief summary

The purpose of this study is to determine whether TACE combined endovascular stent implantation confers a survival benefit over TACE alone.

Interventions

PROCEDUREchemoembolization

Conventional chemoembolisation by administering Doxorubicin and Oxaliplatin mix with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI.

DEVICEendovascular stents implantation

Bare stents implant within portal vein.

PROCEDUREiodine-125 seed strand implantation

Iodine-125 seed strand implant within portal vein.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

* (1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the American Association for the Study of Liver Diseases (AASLD) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on CT or MRI; * (2) Child-Pugh classification grade A or B； * （3）Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.

Exclusion criteria

* advanced liver disease (bilirubin levels \>3 mg/dL, ASTor ALT \>5 × upper limit of normal)； * Tumor invade the Inferior Vena Cava, extrahepatic spread; * contraindications for doxorubicin or oxaliplatin chemotherapy; * any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %); * renal failure,cardiac ejection fraction \<50 %) or end-stage disease； * patients who were not capable of cooperation during the procedure.

Design outcomes

Primary

Measure	Time frame
Median survival time	2 years

Secondary

Measure	Time frame
Time to Disease Progression	2 years

Countries

China

Outcome results

None listed

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