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Combination Treatment for Advanced Liver Cancer

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ClinicalTrials.gov Identifier: NCT02149771
Recruitment Status : Withdrawn (Insufficient funding)
First Posted : May 29, 2014
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Shanghai Municipal Science and Technology Commission
Information provided by (Responsible Party):
Zhiping Yan, 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Hepatic Portal Vein Tumor Invasion Procedure: chemoembolization Device: endovascular stents implantation Procedure: iodine-125 seed strand implantation Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Arm Intervention/treatment
Experimental: TACE&Stents
chemoembolization combined with endovascular stents and iodine-125 seed strand implantation
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Median survival time [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Time to Disease Progression [ Time Frame: 2 years ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149771


Locations
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China, Shanghai
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Shanghai Municipal Science and Technology Commission
Investigators
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Principal Investigator: Zhinping Yan, MD Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Study Director: Jianjun Luo, MD Department of Interventional Radiology, Zhongshan Hospital, Fudan University

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Responsible Party: Zhiping Yan, Prof., Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02149771     History of Changes
Other Study ID Numbers: ZS-IR 2013
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Keywords provided by Zhiping Yan, Shanghai Zhongshan Hospital:
hepatocellular carcinoma
portal vein tumor thrombosis
stents
chemoembolization
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs