NCT03969576Unknown不适用
Efficacy and Safety of Drug-eluting Bead TACE VS Conventional TACE for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective Cohort Study
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2020年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
this multi-center prospective cohort study is to evaluate the efficacy and the safety of drug-eluting bead TACE compared with conventional TACE in terms of objective response in unresectable HCC
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior informed consent
- •Confirmed Diagnosis of HCC: a. Cirrhotic subjects: Clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria. HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria. b. Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory. Documentation of original biopsy for diagnosis is acceptable
- •Patients with unresectable Barcelona Clinic Liver Cancer (BCLC) stage A and BCLC B, and all patients have a intermediate or high tumor burden (the diameter of largest tumor plus tumor number is more than 6)
- •Child Pugh class A/B(7) class without decompensated liver cirrhosis.
- •ECOG Performance Status 0 score
- •At least one uni-dimensional lesion measurable by MRI or CT according to the RECIST 1.1 criteria
- •Male or female subject larger than 18 years of age
- •Life expectance of at least 12 weeks.
- •Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
- •Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
- •Hemoglobin > 9.0 g/dl
- •Absolute neutrophil count (ANC) >1,500/mm3
- •Platelet count≥50x109/L
- •Total bilirubin < 2 mg/dL
- •Alanine aminotransferase(ALT) and aspartate aminotransferase(AST) < 5 x upper limit of normal
- •Blood urea nitrogen(BUN) and creatinine < 1.5 x upper limit of normal
- •International normalized ratio(INR) < 1.7, or prothrombin time（PT） < 4 seconds above control
排除标准
- •Portal vein or any vascular invasion
- •Presence of extra hepatic spread
- •Presence of metastasis in biliary tract or obstruction of biliary tract
- •Presence of metastasis in brain or presence of symptom of the brain metastasis but lack of further examination to exclude brain metastasis
- •Poor blood supply for the liver tumor lesions; poor blood supply refers that the tumor lesions fail to show obvious contrast uptake in the arterial phase and washout in venous or late phases by CT scan or MRI
- •Any contraindications for hepatic embolization procedures:
- •Known hepatofugal blood flow
- •Known porto-systemic shunt
- •Renal failure / insufficiency requiring hemo-or peritoneal dialysis
- •History of cardiac disease:
- •Congestive heart failure >New York Heart Association (NYHA) class 2
- •Uncontrolled hypertension
- •Known history of HIV infection
- •Patients who have previously been receiving any treatments against HCC
- •Active clinically serious infections (> grade 2 NCI-CTCAE Version 4.0), except for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection
- •Contraindication of Anthracyclines administration, such as Doxorubicin
- •Concurrent with other cancer
- •Pregnant or breast-feeding subjects
- •Women of childbearing age did not take any contraceptive measures
- •Clinically significant gastrointestinal bleeding within 12 weeks prior to start of study
- •Major surgery within 3 weeks prior to start of study drug (e.g. thoracolaparotomy is not allowed, but noninvasive surgery, e.g. biopsy, is allowed)
结局指标
主要结局
Objective response rate
时间窗: Tumor response will be assessed at week 4 and week 12 after initiation of treatment and thereafter every 8 weeks, up to 1 year
the percentage of patients who achieved complete response (CR) and partial response (PR) as the best response, according to the modified Response Evaluation Criteria In Solid Tumours (mRECIST) criteria
次要结局
- Progression-free survival(The last patient has been on study for 1year)
- Time to response(The last patient has been on study for 1year)
- Adverse event(The adverse event will be assessed during in hospital and every 4 weeks, up to 1year)
- Overall survival(The last patient has been on study for 1year)
- Time to progression(The last patient has been on study for 1year)
- Duration of response(The last patient has been on study for 1year)
研究者
Guohong Han
Principal Investigator
Air Force Military Medical University, China
研究点 (1)
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