NCT05057104尚未招募不适用
Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy
Beijing 302 Hospital0 个研究点目标入组 320 人开始时间: 2021年10月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 主要终点
- Overall survival time
研究概览
简要总结
To compare the prognosis and adverse reactions of unresectable hepatocellular carcinoma receiving stereotactic radiotherapy combined with hepatic arterial chemoembolization and conversion hepatectomy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable HCC patients were diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
- •Patients who received SBRT plus TACE have tumor regression, and surgical experts assess that R0 resection could be achieved
- •CP-A or B classification;
- •Eastern Cooperative Oncology Group (ECOG) score 0-1;
- •Platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;
- •ICG R15≤10%;
- •Normal effective liver volume >30%;
- •patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.
排除标准
- •the patients receive other treatments (such as targeted treatment, immune checkpoint inhibitors,etc) after CK-SBRT plus TACE.
结局指标
主要结局
Overall survival time
时间窗: From date of randomization until the date of death from any cause, assessed up to 24 months.
次要结局
- Progression-free survival time(From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 24 months.)
- Radiation-induced liver injury rates(From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.)
- Adverse reaction(From the date of radiotherapy completion until the 4 months after therapy,up to 6 months)
研究者
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