Combination Treatment for Advanced Liver Cancer

Study Overview
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma, Hepatic Portal Vein Tumor Invasion

Intervention / Treatment
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* Procedure: chemoembolization
* Device: endovascular stents implantation
* Procedure: iodine-125 seed strand implantation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACE&Stents<br>chemoembolization combined with endovascular stents and iodine-125 seed strand implantation | Procedure: chemoembolization<br>* 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.<br>Device: endovascular stents implantation<br>* Bare stents implant within portal vein.<br>Procedure: iodine-125 seed strand implantation<br>* Iodine-125 seed strand implant within portal vein.<br>|
| Active Comparator: TACE<br>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. | Procedure: chemoembolization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median survival time |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Progression |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, portal vein tumor thrombosis, stents, chemoembolization