NCT04150744招募中2 期
Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS.
详细描述
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS. 120 patients were enrolled into two groups respectively, the experimental group and reference group.
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
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •Age from 18-75 years
- •Diagnosis as hepatocellular carcinoma from histology and cytology
- •BCLC B-C degree
- •Score of ECOG PS: 0-2
- •Child-Pugh Score: A or B
- •Not suitable for resection or liver transplantation
- •Have not received systemic therapy
- •Have at least one evaluable target mass from CT or MRI according to mRECIST
- •The estimated survival time ≥ 12 weeks
- •Patients with HBV infection having HBV-DNA <500IU/mL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment.
- •The function of main organs normal
- •Sign informed consent
排除标准
- •Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years.
- •Have local ablation, TACE or radiotherapy in 3 months before enrolled.
- •Prepared to or have received organic or bone marrow transplantation.
- •Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices.
- •Have hypertension and can't lower down to the normal level using blood pressure medication.
- •Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia.
- •Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction.
- •Have gastrointestinal bleeding in 6 months
- •Have abdominal fistula, gastrointestinal perforation or abdominal abscess
- •Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung.
- •Routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g
- •Patients have autoimmune disease
- •Patients need corticosteroid or other immunosuppressant therapy
- •Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months
- •Allergy to monocloning antibody
- •Pregnant or breastfeeding female Other patients not suitable to be enrolled in the study.
研究组 & 干预措施
RFA plus carrizumab
Experimental
干预措施: radiofrequency ablation (Combination Product)
carrizumab
Placebo Comparator
干预措施: radiofrequency ablation (Combination Product)
结局指标
主要结局
Progression-free survival
时间窗: through study completion, an average of 4 years
Time from patients received treatment fist time to disease progress or death
次要结局
- Overall survival(through study completion, an average of 4 years)
- Objective response rate(through study completion, an average of 4 years)
- Disease control rate(through study completion, an average of 4 years)
- Duration of response(through study completion, an average of 4 years)
研究者
研究点 (1)
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