Neoplasms

All Conditions

Heart and Blood Diseases

Digestive System Diseases

Carcinoma

Thrombosis

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Embolism

Embolism and Thrombosis

Vascular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Epirubicin

Chlorotrianisene

Iodine

Ethiodized Oil

Cadexomer iodine

Anti-Infective Agents, Local

Trace Elements

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

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.

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.

Stent and Iodine-125 seed strand implantation

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

Stent

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.

Iodine-125 seed

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

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

Ultra-fluid lipiodol

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

Gelatin sponge articles

Zihan Zhang, MD

Wen Zhang, MD

Jianjun Luo, MD

Zhinping Yan, MD

Zhiping Yan, MD

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.

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.

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

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

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.

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

Shanghai Zhongshan Hospital

Spots Global Cancer Trial Database for endovascular brachytherapy