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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02971345
• Other study ID #: ZS-IR-2016
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: November 2020

Study information

• Verified date: June 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Zihan Zhang, MD
• Phone: +8615901785843
• Email: zhangzihan0217[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 253
• Est. completion date: November 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• (1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased a-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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Portal Vein Tumor Thrombus
• Thrombosis

Intervention

Procedure:
• Stent and Iodine-125 seed strand implantation
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.

Device:
• Stent
Bare stent should be placed through a 7-F, 23-cm-long sheath over the wire.
• Iodine-125 seed
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.

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

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

Locations

Country	Name	City	State
China	Department of Interventional Radiology, Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (28)

Lead Sponsor

Collaborator

Shanghai Zhongshan Hospital

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 Second People's Hospital of Yibin, Wuhan Union Hospital, China, Yancheng Third People's Hospital, Zhejiang University, Zhongshan Hospital Xiamen University, ZhuHai Hospital

Country where clinical trial is conducted

China, 

References & 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. d — View 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 — View 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 thro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		From the date of randomization until the date of death from any cause, assessed up to 24 months
Secondary	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.	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