Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein T… (NCT02971345) | Clinical Trial Compass
UnknownPhase 3
Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus
China253 participantsStarted 2017-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 Ă— 109/L or prothrombin activity below 50 %);
* (5) Renal failure,cardiac ejection fraction (\<50 %) or end-stage disease;
* (6) Patients who wer…
What they're measuring
1
Overall Survival
Timeframe: From the date of randomization until the date of death from any cause, assessed up to 24 months