Combination Treatment for Advanced Liver Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Hepatocellular Carcinoma Hepatic Portal Vein Tumor Invasion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TACE&Stents

chemoembolization combined with endovascular stents and iodine-125 seed strand implantation

Group Type EXPERIMENTAL

chemoembolization

Intervention Type PROCEDURE

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.

endovascular stents implantation

Intervention Type DEVICE

Bare stents implant within portal vein.

iodine-125 seed strand implantation

Intervention Type PROCEDURE

Iodine-125 seed strand implant within portal vein.

TACE

Transartery chemoembolisation（TACE） by administering Doxorubicin and Oxaliplatin mixed 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.

Group Type ACTIVE_COMPARATOR

chemoembolization

Intervention Type PROCEDURE

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.

Interventions

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chemoembolization

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.

Intervention Type PROCEDURE

endovascular stents implantation

Bare stents implant within portal vein.

Intervention Type DEVICE

iodine-125 seed strand implantation

Iodine-125 seed strand implant within portal vein.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No