Clinical trial NCT02971345: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Portal Vein Tumor Thrombus
Keywords: Hepatocellular carcinoma
main portal vein tumor thrombus
endovascular brachytherapy
stent
chemoembolization
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: RenJi Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: The First Affiliated Hospital of Soochow University
name: The First Affiliated Hospital with Nanjing Medical University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Lishui Country People's Hospital
name: Zhejiang University
name: Changhai Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: The First Affiliated Hospital of Anhui Medical University
name: The Second People's Hospital of Yibin
name: The First Affiliated Hospital of Shanxi Medical University
name: LanZhou University
name: The First Affiliated Hospital of Zhengzhou University
name: First Hospital of China Medical University
name: Fujian Medical University Union Hospital
name: Fujian Provincial Hospital
name: Wuhan Union Hospital, China
name: ZhuHai Hospital
name: Zhongshan Hospital Xiamen University
name: Yancheng Third People's Hospital
name: Changzhou Wujin People's Hospital
name: Tengzhou Central People's Hospital
name: Harbin Medical University
name: Hunan Cancer Hospital
name: First Affiliated Hospital of Zhejiang University
First posted: 2016-11-22
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Survival
timeFrame: From the date of randomization until the date of death from any cause, assessed up to 24 months
Secondary outcomes:
measure: Time To Progression
timeFrame: 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
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Interventional Radiology, Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Interventional Radiology, Zhongshan Hospital, Fudan University
name: Zhiping Yan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Interventional Radiology, Zhongshan Hospital, Fudan University
name: Jianjun Luo, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.