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

Primary Purpose

Hepatocellular Carcinoma, Portal Vein Tumor Thrombus

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Stent and Iodine-125 seed strand implantation

Stent

Iodine-125 seed

Epirubicin

Ultra-fluid lipiodol

Gelatin sponge articles

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, main portal vein tumor thrombus, endovascular brachytherapy, stent, chemoembolization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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;
(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.

Sites / Locations

Department of Interventional Radiology, Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endovascular Brachytherapy&Stent&TACE

TACE alone

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Time To Progression

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.

Full Information

NCT ID

NCT02971345

First Posted

November 20, 2016

Last Updated

June 9, 2020

Sponsor

Shanghai Zhongshan Hospital

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

1. Study Identification

Unique Protocol Identification Number

NCT02971345

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

October 2020 (Anticipated)

Study Completion Date

November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Portal Vein Tumor Thrombus

Keywords

Hepatocellular carcinoma, main portal vein tumor thrombus, endovascular brachytherapy, stent, chemoembolization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

253 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endovascular Brachytherapy&Stent&TACE

Arm Type

Experimental

Arm Description

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.

Arm Title

TACE alone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Stent and Iodine-125 seed strand implantation

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Stent

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Iodine-125 seed

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Epirubicin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ultra-fluid lipiodol

Other Intervention Name(s)

lipiodol

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Gelatin sponge articles

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

From the date of randomization until the date of death from any cause, assessed up to 24 months

Secondary Outcome Measure Information:

Title

Time To Progression

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zihan Zhang, MD

Phone

+8615901785843

zhangzihan0217@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Wen Zhang, MD

Phone

+8613774267409

wenzhangxiao@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiping Yan, MD

Organizational Affiliation

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jianjun Luo, MD

Organizational Affiliation

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Official's Role

Study Director

Facility Information:

Facility Name

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianjun Luo, MD

zhangzihan0217@126.com

First Name & Middle Initial & Last Name & Degree

Zhinping Yan, MD

First Name & Middle Initial & Last Name & Degree

Jianjun Luo, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

21463757

Citation

Luo J, Yan Z, Liu Q, Qu X, Wang J. Endovascular placement of iodine-125 seed strand and stent combined with chemoembolization for treatment of hepatocellular carcinoma with tumor thrombus in main portal vein. J Vasc Interv Radiol. 2011 Apr;22(4):479-89. doi: 10.1016/j.jvir.2010.11.029.

Results Reference

result

PubMed Identifier

26341514

Citation

Luo JJ, Zhang ZH, Liu QX, Zhang W, Wang JH, Yan ZP. Endovascular brachytherapy combined with stent placement and TACE for treatment of HCC with main portal vein tumor thrombus. Hepatol Int. 2016 Jan;10(1):185-95. doi: 10.1007/s12072-015-9663-8. Epub 2015 Sep 4.

Results Reference

result

PubMed Identifier

24374800

Citation

Yang M, Fang Z, Yan Z, Luo J, Liu L, Zhang W, Wu L, Ma J, Yang Q, Liu Q. Transarterial chemoembolisation (TACE) combined with endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus TACE alone: a two-arm, randomised clinical trial. J Cancer Res Clin Oncol. 2014 Feb;140(2):211-9. doi: 10.1007/s00432-013-1568-0. Epub 2013 Dec 28. Erratum In: J Cancer Res Clin Oncol. 2014 Apr;140(4):687-8.

Results Reference

result

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

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