PRECISION V c-TACE vs d-TACE
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药物洗脱微球PRECISION V 随机对照研究

时间:2023-09-03 21:11来源:www.ynjr.net 作者:杨宁介入医学网
International multicentre, randomized phase II study of DC Bead uploaded with doxorubicin versus conventional Lipiodol TACE with doxorubicin Primary endpoint: tumor response at 6 months (EASL criteria by blinded independent review of MR im



国际多中心,随机II期研究DC Bead与传统lipodol TACE与阿霉素

International multicentre, randomized phase II study of DC Bead uploaded with doxorubicin versus conventional Lipiodol TACE with doxorubicin



  • 主要终点:6个月时肿瘤反应(通过MR图像的盲法独立审查EASL标准)
  • 次要终点包括安全性(根据SWOG的毒性)
• Primary endpoint: tumor response at 6 months (EASL criteria by blinded independent review of MR images)
• Secondary endpoints included safety (toxicity according to SWOG)

SWOG癌症研究网络是由美国国家癌症研究所(NCI)资助的一个癌症临床试验小组
 

TACE with DC Bead vs conventional TACE: enrollment criteria


Main Inclusion Criteria Main Exclusion Criteria
• Patient with large / multinodular HCC without vascular invasion or extrahepatic spread
 
• Patient not suitable for curative resection / ablation
 
• ECOG performance status 0 or 1
 
• Child Pugh A or B
 
• Recurrent tumor after resection or ablation
 
• Patients on the transplant list who may not receive a transplant within 6 months
• Severe liver dysfunction
- Child C
- Bilirubin level >3mg/dl
 
• Advanced tumour stage
 
- tumor involvement > 50% of the whole liver
- macroscopic vascular invasion
- extrahepatic spread
 
• Patient previously treated  with
chemo- or radiotherapy                                                                                                                                                

TACE with DC Bead vs conventional TACE: treatment-related adverse events *




TACE with DC Bead vs conventional TACE: doxorubicin-related adverse events




TACE with DC Bead vs conventional TACE: cardiac toxicity (LV ejection fraction)



TACE with DC Bead vs conventional TACE: liver toxicity (ALT-AST levels)



TACE with DC Bead vs conventional TACE: severe adverse events




TACE with DC Bead vs conventional TACE: tumor response at 6 months




TACE with DC Bead vs conventional TACE: tumor response at 6 months
1. Llovet JM et al. Lancet 2002;359:1734–9
2. Lo CM et al. Hepatology 2002;35:1164–71

TACE with DC Bead vs conventional TACE: tumor response – subgroup analysis



TACE with DC Bead vs conventional TACE: tumor response – subgroup analysis
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