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Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02971345
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Ruijin Hospital
RenJi Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
The First Affiliated Hospital of Soochow University
The First Affiliated Hospital with Nanjing Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lishui Country People's Hospital
Zhejiang University
Changhai Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The First Affiliated Hospital of Anhui Medical University
The Second People's Hospital of Yibin
The First Affiliated Hospital of Shanxi Medical University
LanZhou University
The First Affiliated Hospital of Zhengzhou University
First Hospital of China Medical University
Fujian Medical University Union Hospital
Fujian Provincial Hospital
Wuhan Union Hospital, China
ZhuHai Hospital
Zhongshan Hospital Xiamen University
Yancheng Third People's Hospital
Changzhou Wujin People's Hospital
Tengzhou Central People's Hospital
Harbin Medical University
Hunan Cancer Hospital
First Affiliated Hospital of Zhejiang University
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and endovascular brachytherapy combined with stent placement and TACE for HCC with main portal vein tumor thrombus.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Portal Vein Tumor Thrombus Procedure: Stent and Iodine-125 seed strand implantation Device: Stent Device: Iodine-125 seed Drug: Epirubicin Drug: Ultra-fluid lipiodol Other: Gelatin sponge articles Phase 3

Detailed Description:
It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Zhi-ping Yan.Investigators in twenty-seven hospitals in China participate in.Patients with unresectable HCC with main portal vein tumor thrombus are enrolled. The investigators propose to recruitment 253 patients who are randomly assigned into the combined group (treated with endovascular brachytherapy combined with stent placement and TACE) and the control group (treated with TACE alone).There are 127 patients in combined group and 126 patients in control group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovascular Brachytherapy Combined With Stent Placement and Transcatheter Arterial Chemoembolization (TACE) for Treatment of HCC With Main Portal Vein Tumor Thrombus Versus TACE Alone: a Prospective Randomized Controlled Multicentre Trial
Study Start Date : January 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Endovascular Brachytherapy&Stent&TACE

Transarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation.

Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

Procedure: Stent and Iodine-125 seed strand implantation
The patent second-order branch of the intrahepatic portal vein was punctured with a 22-gauge Chiba needle under ultrasound guidance.Stent and Iodine-125 seed strand are implanted by two 0.035-inch,150-cm-long wire.

Device: Stent
Bare stent should be placed through a 7-F, 23-cm-long sheath over the wire.

Device: Iodine-125 seed
The number of Iodine-125 seeds planned to be implanted was calculated by the following formula: N = length of obstructed main portal vein (mm)/4.5 + 4. These seeds were arranged linearly and sealed into a 4-F catheter continuously to construct a Iodine-125 seed strand.

Drug: Epirubicin
Epirubicin is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: Epirubicin 30-60 mg per patient,depending on the situation of the patient.

Drug: Ultra-fluid lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Other Name: lipiodol

Other: Gelatin sponge articles
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.

Active Comparator: TACE alone
Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Drug: Epirubicin
Epirubicin is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: Epirubicin 30-60 mg per patient,depending on the situation of the patient.

Drug: Ultra-fluid lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Other Name: lipiodol

Other: Gelatin sponge articles
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From the date of randomization until the date of death from any cause, assessed up to 24 months ]

Secondary Outcome Measures :
  1. Time To Progression [ Time Frame: From the date of first procedure of TACE or combined therapy until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 24 months ]
    Time to progression follow-up is done at three months interval after lesions defined as stable with treatment of TACE or combined therapy six months after enrollment until lesions are defined as disease progression.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 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;
  • (2) According to the Barcelona Clinic Liver Cancer staging classification, HCC was unsuitable for resection, liver transplantation or percutaneous radiofrequency ablation;
  • (3) Tumor thrombus, a low-attenuation intraluminal filling defect extending from intrahepatic portal vein branches adjacent to primary tumor into main portal vein, was confirmed by contrast-enhanced abdominal computer tomography (CT) or magnetic resonance imaging (MRI)
  • (4) At least the first-order branch of the intrahepatic portal vein was patent in one lobe;
  • (5) Child-Pugh classification grade A or B;
  • (6) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;

Exclusion Criteria:

  • (1) Patients had a history of any therapy for HCC or portal vein tumor thrombus;
  • (2) Advanced liver disease (bilirubin levels >3 mg/dL, Aspartate transaminase or Alanine aminotransferase >5 × upper limit of normal);
  • (3) Tumor invade the Inferior Vena Cava, extrahepatic spread;
  • (4) Any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
  • (5) Renal failure,cardiac ejection fraction (<50 %) or end-stage disease;
  • (6) 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): NCT02971345


Contacts
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Contact: Zihan Zhang, MD +8615901785843 zhangzihan0217@126.com
Contact: Wen Zhang, MD +8613774267409 wenzhangxiao@126.com

Locations
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China, Shanghai
Department of Interventional Radiology, Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jianjun Luo, MD       zhangzihan0217@126.com   
Principal Investigator: Zhinping Yan, MD         
Sub-Investigator: Jianjun Luo, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Ruijin Hospital
RenJi Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
The First Affiliated Hospital of Soochow University
The First Affiliated Hospital with Nanjing Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lishui Country People's Hospital
Zhejiang University
Changhai Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The First Affiliated Hospital of Anhui Medical University
The Second People's Hospital of Yibin
The First Affiliated Hospital of Shanxi Medical University
LanZhou University
The First Affiliated Hospital of Zhengzhou University
First Hospital of China Medical University
Fujian Medical University Union Hospital
Fujian Provincial Hospital
Wuhan Union Hospital, China
ZhuHai Hospital
Zhongshan Hospital Xiamen University
Yancheng Third People's Hospital
Changzhou Wujin People's Hospital
Tengzhou Central People's Hospital
Harbin Medical University
Hunan Cancer Hospital
First Affiliated Hospital of Zhejiang University
Investigators
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Principal Investigator: Zhiping Yan, MD Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Study Director: Jianjun Luo, MD Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Publications of Results:
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02971345    
Other Study ID Numbers: ZS-IR-2016
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Keywords provided by Shanghai Zhongshan Hospital:
Hepatocellular carcinoma
main portal vein tumor thrombus
endovascular brachytherapy
stent
chemoembolization
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Thrombosis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Iodine
Cadexomer iodine
Epirubicin
Ethiodized Oil
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors