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

• Status: Recruiting
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Changhai Hospital; Changzhou Wujin People's Hospital; First Affiliated Hospital of Zhejiang University; First Hospital of China Medical University; Fujian Medical University Union Hospital; Fujian Provincial Hospital; Harbin Medical University; Hunan Cancer Hospital; LanZhou University; Lishui Country People's Hospital; RenJi Hospital; Ruijin Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Tengzhou Central People's Hospital; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Shanxi Medical University; The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital with Nanjing Medical University; The First Hospital of Lanzhou University; The Second People's Hospital of Yibin; Wuhan Union Hospital, China; Yancheng Third People's Hospital; Zhejiang University; Zhongshan Hospital Xiamen University; ZhuHai Hospital
• Treatments: Cadexomer iodine; Epirubicin; Ethiodized Oil; Iodine

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.