NCT04483284进行中（未招募）2 期
Exploratory Clinical Study of TACE Combined With Camrelizumab in the Treatment of BCLC Stage B and Stage C Hepatocellular Carcinoma
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年6月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.
详细描述
This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients voluntarily entered the study and signed informed consent form (ICF)
- •Age: 18 - 80 years old and life expectancy of at least 12 weeks.;
- •Clinically or histologically diagnosed as HCC;
- •There are measurable lesions that meet the RECIST1.1 standard on the baseline imaging examination;
- •Child-pugh classification A or B (score < 7);
- •The BCLC stage is stage B or C, and it is unable or unwilling to undergo surgical treatment;
- •ECOG : 0 ~ 1 ;
- •No previous immune checkpoint inhibitor treatment (including PD-1 / PD-L1 antibody and CTLA-4 inhibitor);
- •HBV-deoxyribonucleic acid (DNA) must be <500IU / mL, and receive at least 14 days of anti-HBV treatment before the start of study treatment Treatment;
排除标准
- •History of treatment with any local treatment (exception of liver transplantation), systemic .anti-cancer therapy, or immunotherapy;
- •Those whose tumor thrombus reaches or exceeds the main portal vein;
- •Existing or concurrently suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
- •There is any active autoimmune disease or has a history of autoimmune disease and may relapse;
- •Use strong CYP3A4 / CYP2C19 inducers including rifampicin and Hypericum perforatum or strong CYP3A4 / CYP2C19 inhibitors within 14 days before starting the study treatment;
- •Known history of severe allergy to any monoclonal antibody;
- •Patients who are going to undergo or have undergone organ or allogeneic bone marrow transplantation;
- •Non-compliance with TACE or Camrelizumab;
- •Moderate and severe ascites with clinical symptoms require therapeutic puncture, drainage, or Childa-Pugh score> 2 (except imaging only shows a small amount of ascites but not accompanied by clinical symptoms); uncontrolled or moderate and Above pleural effusion and pericardial effusion;
- •Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of the study treatment;
- •Thrombosis or embolism occurred within 6 months before the start of study treatment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism, etc.)
- •Known inherited or acquired bleeding or thrombophilia ; currently or recently (10 days prior to the start of study treatment) have used full dose oral or Injection of anticoagulant drugs or thrombolytic drugs (prophylactic use of low-dose aspirin and low molecular weight heparin);
- •Major vascular disease within 6 months before the study treatment;
- •Past or present central nervous system metastasis;
- •Metastatic diseases involving major airways or blood vessels or a large mediastinal tumor mass in the center (<30 mm from the crest)
- •Those with a history of hepatic encephalopathy;
- •Palliative radiotherapy for non-target lesions allowed for symptom control must be completed at least 2 weeks before the start of study treatment. Adverse events caused by radiotherapy have not recovered to ≤CTCAE level 1;
- •There were severe infections within 4 weeks before starting the study treatment;
- •Patients with congenital or acquired immune deficiency (such as those infected with HIV);
- •Co-infection with hepatitis B and C;
- •For patients with bone metastases, the palliative radiotherapy area> 5% bone marrow area received within 4 weeks before participating in the study;
研究组 & 干预措施
TACE combined with Camrelizumab
Experimental
Camrelizumab（200mg q3w ivgtt）combined with TACE,the interval between TACE treatment and Carilizumab is not less than 7 days.
干预措施: TACE combined with Camrelizumab (Drug)
TACE combined with Camrelizumab
Experimental
Camrelizumab（200mg q3w ivgtt）combined with TACE,the interval between TACE treatment and Carilizumab is not less than 7 days.
干预措施: TACE plus Camrelizumab (Procedure)
结局指标
主要结局
Progression Free Survival
时间窗: an expected average of 8 months
the time from enrollment to the first disease progression or death from any cause
次要结局
- Overall survival(An expected average of 24 months)
- Time to progression(An expected average of 8 months)
- Objective response rate(An expected average of 8 months)
- Duration of response(An expected average of 8 months)
- Disease control rate(An expected average of 8 months)
- The incidence of AEs and SAEs by NCI-CTCAE v5.0(An expected average of 8 months)
研究者
研究点 (1)
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