NCT02529761Unknown不适用
Transarterial Chemoembolization (TACE) With or Without Sorafenib in Intermediate Stage Hepatocellular Carcinoma: a Multicenter Prospective Nonrandomized Study
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This multicenter prospective nonrandomized study is to evaluate the efficacy of TACE combined with sorafenib compared with TACE monotherapy in term of overall survival in intermediate-stage HCC.
详细描述
Sorafenib, a multikinase inhibitor, has been successfully applied for solid tumors such as renal cancer and HCC.
According to the Barcelona Clinic Liver Cancer (BCLC) staging classification, transarterial chemoembolization (TACE) has been recommended as a first line-therapy for patients at intermediate stage - BCLC B class (multinodular asymptomatic tumors without an invasive pattern).
Because sorafenib may improve the efficacy of locoregional therapy by decreasing post-TACE angiogenesis, sorafenib in combination with TACE has attracted considerable attention as a promising therapy
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
- None
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
- •Intermediate stage HCC/ BCLC B stage
- •Confirmed Diagnosis of HCC:
- •Cirrhotic subjects: Clinical diagnosis by 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.
- •Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory. Documentation of original biopsy for diagnosis is acceptable
- •Child Pugh class A/B(7) class without ascites or hepatic encephalopathy
- •ECOG Performance Status of 0-1
- •At least one uni-dimensional lesion measurable by CT-scan or MRI according to the RECIST 1.1, mRECIST and EASL criteria, respectively.
- •Single lesion>5cm
- •2-3 lesions, at least one lesion>3cm; if more than 4 lesions, no limitation of the tumor size, but the sum of size of all tumor lesions should be less than 50% of liver parenchyma.
- •Male or female subject ≥ 18 years of age
- •Ability to swallow oral medications
- •Life expectancy of at least 12 weeks
- •Pregnancy test negative within 14 days before treatment. 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 functions 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
- •ALT and AST < 5 x upper limit of normal
- •BUN and creatinine < 1.5 x upper limit of normal
- •INR < 1.7, or PT < 4 seconds above control
排除标准
- •Diffuse HCC or tumor size ≥50% of liver parenchyma
- •Vascular invasion
- •Presence of extrahepatic 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
- •Target lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI)
- •Investigational drugs or other molecular target drugs ongoing or completed < 4 weeks prior to the baseline scan
- •Prior transarterial embolization or anti-tumor systemic chemotherapy
- •Any ≥ CTC AE grade 2 acute toxic effects of any prior local treatment
- •Patients with untreated varices or active bleeding
- •History of cardiac disease:
- •Congestive heart failure >New York Heart Association (NYHA) class 2
- •Uncontrolled hypertension
- •Known history of HIV infection
- •Active clinically serious infections (> grade 2 NCI-CTCAE Version 4.0), except for HBV and HCV infection
- •Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
- •Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug
- •Previous or concurrent cancer that is distinct in primary site or histology from HCC. Any cancer curatively treated >3 years prior to entry is permitted
- •Any contraindication for sorafenib or doxorubicin administration
- •Pregnant or breast-feeding subjects
- •Any disease which could affect the evaluation of the study drug: unstable angina, active CAD, uncontrolled arrhythmias, and myocardial infarction
- •Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
- •Major surgery within 4 weeks prior to start of study drug (e.g. thoracolaparotomy is not allowed, but noninvasive surgery, e.g. biopsy, is allowed)
- •Autologous bone marrow transplant or stem cell rescue within 1 year prior to start of study drug
- •History of organ allograft
研究组 & 干预措施
Sorafenib combined with TACE
Experimental
220 subjects in this study group will receive the treatment of sorafenib combined with conventional TACE.
干预措施: Sorafenib (Drug)
Sorafenib combined with TACE
Experimental
220 subjects in this study group will receive the treatment of sorafenib combined with conventional TACE.
干预措施: TACE (Procedure)
TACE monotherapy
Active Comparator
110 subjects in this study group will receive the treatment of conventional TACE monotherapy.
干预措施: TACE (Procedure)
结局指标
主要结局
Overall survival
时间窗: The last patient has been on study for 1.5 year
Overall survival analysis is measured from the treatment start until death occurred from any cause
次要结局
- Tumor response(Tumor response will be assessed at week 4 and week 8 after initiation of treatment and thereafter every 8 weeks (±7 days), up to 3 years)
- Adverse events(The adverse events will be assessed every 4 weeks, up to 3 years)
- Prognostic factor(The analysis will be perfomed when the last patient has been on study for 1.5 year)
- Time to progression(The time to progression will be assessed at the end of the study, up to 3 years)
研究者
Guohong Han
Director
Air Force Military Medical University, China
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
TACE Combined With Methylcantharidimide Tablets in the Treatment of Large and Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaNCT03996681Suzhou Municipal Hospital22
已完成
2 期
TACE Combined With Sorafenib and Tislelizumab for Advanced HCCHepatocellular Carcinoma Non-resectableNCT04599777Second Affiliated Hospital of Guangzhou Medical University30
已完成
2 期
TACE Combined With Lenvatinib and Sintilimab for Advanced HCCHepatocellular Carcinoma Non-resectableNCT04599790Second Affiliated Hospital of Guangzhou Medical University30
进行中（未招募）
3 期
A Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) in Patients With Incurable Hepatocellular CarcinomaHepatocellular CarcinomaNCT05320692Jiangsu HengRui Medicine Co., Ltd.423
已完成
2 期
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or CarboplatinUnresectable Intrahepatic CholangiocarcinomaNCT01648023Robert C. Martin49