Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus
- Conditions
- Portal Vein Tumor ThrombusHepatocellular Carcinoma
- Interventions
- Procedure: Stent and Iodine-125 seed strand implantationDevice: StentDevice: Iodine-125 seedOther: Gelatin sponge articles
- Registration Number
- NCT02971345
- Lead Sponsor
- Shanghai Zhongshan Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 253
- (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;
- (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endovascular Brachytherapy&Stent&TACE Stent 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. Endovascular Brachytherapy&Stent&TACE Stent and Iodine-125 seed strand implantation 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. Endovascular Brachytherapy&Stent&TACE Ultra-fluid lipiodol 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. TACE alone Ultra-fluid lipiodol Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE. Endovascular Brachytherapy&Stent&TACE Iodine-125 seed 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. Endovascular Brachytherapy&Stent&TACE Gelatin sponge articles 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. TACE alone Gelatin sponge articles Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE. Endovascular Brachytherapy&Stent&TACE Epirubicin 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. TACE alone Epirubicin Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
- Primary Outcome Measures
Name Time Method Overall Survival From the date of randomization until the date of death from any cause, assessed up to 24 months
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (1)
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China