NCT04974281Unknown早期 1 期
Efficacy and Safety of PD-1 Antibody and Lenvatinib Plus TACE on Downstaging Hepatocellular Carcinoma With BCLC B/C
适应症
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Resection rate
研究概览
简要总结
The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C.
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
- •Age ≥18 years old and ≤75 years old;
- •Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC;
- •No history of severe arrhythmia or heart failure;
- •No history of severe ventilation dysfunction or severe pulmonary infection;
- •No acute or chronic renal failure, the creatinine clearance rate was >40 mL/min;
- •Liver function Child A;
- •Blood routine: absolute neutrophils count ≥1.5×10^9/L, Hb≥8.5g/L, PLT≥75×10^9/L;
- •Coagulation function: INR≤2.3;
- •ECOG score <2;
- •No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment;
- •Expected survival ≥12 weeks;
- •At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria;
- •Understand and sign the informed consent.
排除标准
- •Pregnant or lactating women;
- •Patients with other malignant tumors;
- •patients with complicated mental illness;
- •patients who have participated in other clinical trials in the last three months;
- •known or suspected allergy to any drug related to the study;
- •Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- •Patients treated with other targeted drugs, PD-L1 antibody and other immunotherapy or FOLFOX systemic chemotherapy after inclusion;
- •Patients with ≥1 + proteinuria indicated by urine routine will receive 24-hour urine protein detection, and patients with ≥1g 24-hour urine protein will not be included in the group.
- •Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants)
- •Patients with uncontrolled hepatitis B/C infection
- •Other conditions that the researcher considers not suitable for inclusion in this study
结局指标
主要结局
Resection rate
时间窗: 6 months after downstaging treatment
Resction rate refers to the proportion of patients who can receive radical surgery after downstaging treatment.
次要结局
- Objective response rate (ORR)(6 months)
- Adverse events (safety)(6 months)
- Overall survival (OS)(2 years)
- Progression free survival (PFS)(6 months)
研究者
Lunxiu Qin
Director, Clinical Professor
Fudan University
研究点 (1)
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