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

NCT02971345 | Unknown Phase 3

• 1 other identifier: ZS-IR-2016
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Portal Vein Tumor Thrombus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

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

Secondary Outcomes (1)

• Time To Progression

  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

Study Arms (2)

Endovascular Brachytherapy&Stent&TACE

EXPERIMENTAL

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; Device: Stent; Device: Iodine-125 seed; Drug: Epirubicin; Drug: Ultra-fluid lipiodol; Other: Gelatin sponge articles

TACE alone

ACTIVE COMPARATOR

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

Drug: Epirubicin; Drug: Ultra-fluid lipiodol; Other: Gelatin sponge articles

Interventions

Stent and Iodine-125 seed strand implantation PROCEDURE

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.

Endovascular Brachytherapy&Stent&TACE

Stent DEVICE

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

Endovascular Brachytherapy&Stent&TACE

Iodine-125 seed DEVICE

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.

Endovascular Brachytherapy&Stent&TACE

Epirubicin DRUG

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

Endovascular Brachytherapy&Stent&TACE; TACE alone

Ultra-fluid lipiodol DRUG

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

Also known as: lipiodol

Endovascular Brachytherapy&Stent&TACE; TACE alone

Gelatin sponge articles OTHER

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

Endovascular Brachytherapy&Stent&TACE; TACE alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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;

You may not qualify if:

• (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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Ruijin Hospital: collaborator
• RenJi Hospital: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Lishui Country People's Hospital: collaborator
• Zhejiang University: collaborator
• Changhai Hospital: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• The Second People's Hospital of Yibin: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• LanZhou University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Hospital of China Medical University: collaborator
• Fujian Medical University Union Hospital: collaborator
• Fujian Provincial Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• ZhuHai Hospital: collaborator
• Zhongshan Hospital Xiamen University: collaborator
• Yancheng Third People's Hospital: collaborator
• Changzhou Wujin People's Hospital: collaborator
• Tengzhou Central People's Hospital: collaborator
• Harbin Medical University: collaborator
• Hunan Cancer Hospital: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator

Study Sites (1)

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 21463757 RESULT

• 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.

  PMID: 26341514 RESULT

• 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.

  PMID: 24374800 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Stents; Epirubicin; Ethiodized Oil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Zhiping Yan, MD

  Department of Interventional Radiology, Zhongshan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

• Jianjun Luo, MD

  Department of Interventional Radiology, Zhongshan Hospital, Fudan University

  STUDY DIRECTOR

Central Study Contacts

Zihan Zhang, MD

CONTACT

+8615901785843; zhangzihan0217@126.com

Wen Zhang, MD

CONTACT

+8613774267409; wenzhangxiao@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2016
• First Posted: November 22, 2016
• Study Start: January 1, 2017
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

CN (1)