Clinical trial · Interventional
Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Portal Vein Tumor Thrombus | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epirubicin | Drug | Epirubicin | ALIAS |
| Gelatin sponge articles | Other | — | UNRESOLVED |
| Iodine-125 seed | Device | — | UNRESOLVED |
| Stent | Device | — | UNRESOLVED |
| Stent and Iodine-125 seed strand implantation | Procedure | — | UNRESOLVED |
| Ultra-fluid lipiodol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endovascular Brachytherapy&Stent&TACE
- description
- 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.
- interventionNames
- Procedure: Stent and Iodine-125 seed strand implantation
- Device: Stent
- Device: Iodine-125 seed
- Drug: Epirubicin
- Drug: Ultra-fluid lipiodol
- Other: Gelatin sponge articles
- type
- ACTIVE_COMPARATOR
- label
- TACE alone
- description
- Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
- interventionNames
- Drug: Epirubicin
- Drug: Ultra-fluid lipiodol
- Other: Gelatin sponge articles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTLuo 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. PMID 21463757
- RESULTLuo 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. PMID 26341514
- RESULTYang 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. PMID 24374800