Combination Treatment for Advanced Liver Cancer

Fudan University

Status and phase: Withdrawn; Phase 3

Conditions: Hepatic Portal Vein Tumor Invasion; Hepatocellular Carcinoma

Treatments: Procedure: chemoembolization; Device: endovascular stents implantation; Procedure: iodine-125 seed strand implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02149771

ZS-IR 2013

Details and patient eligibility

About

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

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

TACE&Stents

Experimental group

Description:

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

Treatment:

Procedure: iodine-125 seed strand implantation

Device: endovascular stents implantation

Procedure: chemoembolization

TACE

Active Comparator group

Description:

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.

Treatment:

Procedure: chemoembolization