NCT04738188招募中不适用
Efficacy and Safety of TACE on Downstaging Hepatocellular Carcinoma Beyond UCSF Criteria: a Multi-center, Randomized, Parallel-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Downstaging success rate
研究概览
简要总结
This is a multicenter, randomized, parallel controlled study to determine the efficacy and safety of transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma beyond University of California, San Francisco (UCSF) criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years of age, of any sex;
- •Patients who have histopathological or cytological proof of hepatocellular carcinoma (HCC) or meet the diagnostic criteria of Diagnosis, management, and treatment of hepatocellular carcinoma(V2017);
- •Beyond UCSF criteria: Diameter of single HCC lesion is between 6.5 cm and 10 cm; The number of tumors ≤3 with the maximum diameter of 4.5-5cm and the total diameter ≤10cm; Multiple HCC lesions ≤5 nodules, each lesion diameter≤4 cm with a total diameter ≤10 cm. Patients cannot be treated with resection or liver transplantation;
- •Patients with stage Ib，IIa，IIb in China liver cancer staging (CNLC) ;
- •Child-Pugh's grade A or B (no more than 7 score);
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
- •Patients with hepatitis B virus (HBV) infection should receive routine antiviral therapy;
- •The function of main organs is normal and meet the following criteria:
- •Outcome of blood routine must meet the following criteria (No blood transfusion or blood products were performed within 4 days, and no g-CSF or other hematopoietic stimulants were used for correction): i. Hemoglobin(HB)≥90 g/L; ii. Absolute neutrophil count (ANC)≥1.5×109/L； iii. Platelet (PLT)≥80×109/L; 2) Outcome of hemal biochemistry examination meet the following criteria: i. Albumin (ALB) ≥29 g/L; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)<2.5 × upper limit of normal (ULN); iii. Total bilirubin (TBIL) ≤2 × ULN; iv. Serum creatinine (SCr) ≤1.25 × ULN, or endogenous creatinine clearance > 45 ml/min (Cockcroft-Gault formula); 3) Patients who have normal livers with an Remnant Liver Volume (RLV)/Standard Liver Volume(SLV) >20% ; Patients who have cirrhosis with an RLV/SLV>40%;
- •Life expectancy of > 3 months;
- •Patients volunteered to participate in this study and signed informed consent, with good compliance.Exclusion Criteria.
排除标准
- •Patients with extrahepatic metastasis or main portal vein /main hepatic vein invasion;
- •Patients with diffuse liver cancer;
- •Patients with myocardial ischemia, myocardial infarction or poor controlled arrhythmia (including QTc≥470 ms) beyond stage Ⅱ; according to New York Heart Association (NYHA) standard, patients with heart failure in stage Ⅲ～Ⅳ; patients with an left ventricular ejection fraction(LVEF) <50%;
- •Abnormal coagulation （International Normalized Ratio(INR)>1.5, Prothrombin Time(PT)>ULN+4s or Activated Partial Thromboplastin Time (APTT) >1.5 ×ULN）,or patients with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- •Patients unsuitable for the study in the opinion of the Investigator;
- •Pregnant or breastfeeding women; women of childbearing ages unless using effective contraception;
- •Patients with mental disorders or history of abuse of psychotropic substances;
- •Infection with human immunodeficiency virus (HIV);
- •A history of liver resection, liver transplantation, interventional therapy, or combined with other malignant tumors;
- •Patients with active infection;
- •Patients with contraindications to TACE or epirubicin;
- •Floating population or with poor compliance;
- •Patients in other clinical trials conducting with experimental-related drugs or devices within 4 weeks.
研究组 & 干预措施
Drug-eluting bead transarterial chemoembolization(DEB-TACE)
Experimental
干预措施: DEB-TACE (Procedure)
Drug-eluting bead transarterial chemoembolization(DEB-TACE)
Experimental
干预措施: Drug-eluting Beads (Device)
Drug-eluting bead transarterial chemoembolization(DEB-TACE)
Experimental
干预措施: Epirubicin (Drug)
conventional transarterial chemoembolization(cTACE)
Active Comparator
干预措施: cTACE (Procedure)
conventional transarterial chemoembolization(cTACE)
Active Comparator
干预措施: Epirubicin (Drug)
结局指标
主要结局
Downstaging success rate
时间窗: Within 6 months after surgery
Criteria for success rate in downstaging meet UCSF criteria or the standard for liver resection.
次要结局
- Duration of downstaging(within 36 months)
- Progression-free survival (PFS)(Within 36 months)
- Complete response (CR)(1, 3, 6 months after surgery)
- Stable disease (SD)(up to 6months after TACE procedure)
- Progressive disease (PD)(1, 3, 6 months after surgery)
- Times of TACE treatments(within 36 months)
- Tumor-free survival (TFS)(Within 36 months)
- Overall survival (OS)(Within 36 months)
- Partial response (PR)(1, 3, 6 months after surgery)
- Objective response (OR)(1, 3, 6 months after surgery)
- Changes of tumor biomarkers (AFP, PIVKA-Ⅱ)(From 7 days before TACE or curative treatments to the endpoints of the trial.(Up to 36 months))
- Changes in liver function(from the date of the first TACE to the end of the clinical trial or the death of the patient，Up to 36months)
- Recurrence rate of Hepatocellular carcinoma(Within 36 months)
研究者
研究点 (1)
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