NCT04157140Unknown2 期
Anlotinib Hydrochloride In Combination With Radiofrequency Ablation And Transcatheter Arterial Chemoembolization in Patients With Middle-advanced Hepatocellular Carcinoma, Open, Single Arm, Exploratory Clinical Trial
Jinglong Chen3 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年11月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Time To Progression(TTP)
研究概览
简要总结
A single-arm, open-label clinical trial, focus on the safety and efficacy of anlotinib hydrochloride in combination with radiofrequency ablation (RFA) and transcatheter arterial chemoembolization(TACE) in patients with middle-advanced hepatocellular carcinoma(HCC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients participate in the study voluntarily and sign informed consent with good compliance.
- •Histological or cytological confirmation of unrespectable middle-advanced hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage Category C or B , liver function child-Pugh class A or B (≤7 points).
- •At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per mRECIST; have not received local therapies including but not limited to TACE, RFA, radiotherapy and cryosurgery.-Eastern Cooperative Oncology Group Performance Status 0 or
- •Life expectancy of at least 3 months.
- •Main organs function is normal. (normal main organs function as defined below: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×109/L, leucocyte (WBC) ≥ 3.0×109/L, Platelet count (PLT) ≥ 70×109/L, Total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ×ULN, Serum creatinine (Cr) ≤ 1.5× ULN or Creatinine Clearance rate(CCr) ≥60ml/min,Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50%)
- •The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.
- •Patients have disease that is not amenable to potentially curative transplantation or ablation
- •Patients who have characterization for targeted therapy treatment, but under poor economic conditions and cannot afford angiogenesis inhibitors recommended by current guidelines, including Lenvatinib, sorafenib, Cabozantinib, Ramolumab, regorafenib, etc.
排除标准
- •History of other malignancy within 5 years or for now (except for non-melanoma skin cancer, cervix in situ carcinoma, superficial Bladder neoplasms).
- •Subject has obstacle in the function of major organs such as heart, lung, liver and kidney
- •Patients who plan liver transplantation.
- •Patients who had previously received treatment with target inhibitors or other immunotherapy against or chemotherapy
- •Patients who had previously received treatment with TACE or or other local therapy or radiotherapy or Chinese medicine treatment within 4 weeks.
- •Liver function status Child-Pugh Class C, with malignant ascites.
- •Participated in other anti-tumor clinical trials within 4 weeks.
- •Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.).
- •Any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>ULN+4s, Activated partial thromboplastin time (APTT) >1.5ULN s, nternational normalized ratio (INR)>1.5
- •Patients who underwent major surgery within 4 weeks.
- •Patients who have got non remissive toxic reactions derived from any treatment, which is over level 1 in CTC AE (4.0).
- •Patients with any severe and/or unable to control diseases，including： Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100) mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥480ms) and patients with Grade 2 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections, which is over level 2 in CTC AE (4.0); Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L); Patients with kidney failure who require hemodialysis or peritoneal dialysis; Patients with a history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g.
- •Patients whose tumors had invaded important blood vessels by imaging or who, as determined by the researchers, were likely to invade important blood vessels during follow-up trial, resulting in fatal bleeding.
- •Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
- •Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
- •Patients with Brain metastases.
- •Patients with cancer thrombus involving whole the main portal vein.
- •Female patients who are pregnant or breastfeeding.
- •Patients with drug abuse history and unable to get rid of or patients with mental disorders.
- •Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment.
- •History of gastrointestinal bleeding due to severe gastroesophageal varices within 4 weeks.
- •Severe active or uncontrolled infections.
- •Patients who had serious adverse effect to Anlotinib.
- •Patients who had serious adverse effect to iodinated contrast agent.
- •Liver cirrhosis, hepatic decompensation, active hepatitis or chronic hepatitis which requires anti-viral treatment. Hepatitis C virus (HCV) antibody test shows positive and titer test shows amount of HCV exceeds upper limit of normal (ULN) after treatment
研究组 & 干预措施
Anlotinib+ TACE+ RFA
Experimental
Anlotinib+ TACE+ RFA
干预措施: Anlotinib (Drug)
Anlotinib+ TACE+ RFA
Experimental
Anlotinib+ TACE+ RFA
干预措施: TACE+RFA (Device)
结局指标
主要结局
Time To Progression(TTP)
时间窗: each 42 days up to progressive disease (PD) (up to 24 months)
Time To Progression is defined as the time from first day of TACE treatment until the first date of either objective disease progression
次要结局
- Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Duration of Response (DOR)(Time Frame: each 42 days up to intolerance the PD or death (up to 24 months))
- Incidence of Treatment-Emergent Adverse Events(Until 30 day safety follow-up visit)
- Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
研究者
Jinglong Chen
Chief of Oncology
Beijing Ditan Hospital
研究点 (3)
Loading locations...
相似试验
Unknown
2 期
Anlotinib Plus Penpulimab (AK105) for Chemo-refractory Metastatic Colorectal Cancer:ALTER-C003Colorectal CancerNCT04970914Peking Union Medical College Hospital32
进行中（未招募）
2 期
Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery RecurrenceTACEAnlotinibHepatocellular CarcinomaNCT04213118First Affiliated Hospital Xi'an Jiaotong University30
Unknown
不适用
Anlotinib Hydrochloride Combined With EGFR-Tyrosine Kinase Inhibitor (TKI) in Treating Advanced NSCLC Patients With Acquired Resistance to EGFR-TKINSCLCNCT04007835Guangdong Association of Clinical Trials120
Unknown
2 期
Anlotinib Hydrochloride Combined With Sintilimab Injection in the Treatment of Advanced Hepatocellular Carcinoma (HCC)Advanced Hepatocellular CarcinomaNCT04052152The First Affiliated Hospital with Nanjing Medical University20
招募中
不适用
Concurrent Radiochemotherapy Plus Anlotinib for Locally Advanced Cervical CancerUterine Cervical NeoplasmsChemoradiotherapyAngiogenesisNCT04772001Zhongnan Hospital53