Combination Treatment for Advanced Liver Cancer

Phase 3

Withdrawn

• Conditions: Hepatocellular Carcinoma; Hepatic Portal Vein Tumor Invasion
• Interventions: Procedure: chemoembolization; Device: endovascular stents implantation; Procedure: iodine-125 seed strand implantation

• Registration Number: NCT02149771
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-25
• Study First Submitted QC: 2014-05-25
• Study First Posted: 2014-05-29
• Primary Completion: 2016-05
• Study Completion: 2016-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE	chemoembolization	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.
TACE&Stents	chemoembolization	chemoembolization combined with endovascular stents and iodine-125 seed strand implantation
TACE&Stents	iodine-125 seed strand implantation	chemoembolization combined with endovascular stents and iodine-125 seed strand implantation
TACE&Stents	endovascular stents implantation	chemoembolization combined with endovascular stents and iodine-125 seed strand implantation

Primary Outcome Measures

Name	Time	Method
Median survival time	2 years

Secondary Outcome Measures

Name	Time	Method
Time to Disease Progression	2 years

Trial Locations

Locations (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China