Combination Treatment for Advanced Liver Cancer

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02149771
• Other study ID #: ZS-IR 2013
• Status: Withdrawn
• Phase: Phase 3
• First received: May 25, 2014
• Last updated: April 17, 2018
• Start date: May 2014
• Est. completion date: September 2016

Study information

• Verified date: April 2018
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• (1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased a-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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatic Portal Vein Tumor Invasion
• Hepatocellular Carcinoma

Intervention

Procedure:
• 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.

Device:
• endovascular stents implantation
Bare stents implant within portal vein.

Procedure:
• iodine-125 seed strand implantation
Iodine-125 seed strand implant within portal vein.

Locations

Country	Name	City	State
China	Department of Interventional Radiology, Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Shanghai Municipal Science and Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median survival time		2 years
Secondary	Time to Disease Progression		2 years