NCT04791176已完成2 期
Phase II Study of Concurrent Lenvatinib and Intensity-modulated Radiotherapy (IMRT) for Advanced Hepatocellular Carcinoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年4月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- MST
研究概览
简要总结
This is a single-arm, open-label study performed at our hospital, patients with progression hepatocellular carcinoma (HCC) met inclusion criteria will be enrolled. Patients received oral lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) before local radiotherapy 4 weeks, large lesions were treated with IMRT for 40-60gy / 20-30f. Combined therapy will be taken until unacceptable treatment-related toxicities occurred or disease progression.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had an HCC diagnosis confirmed either histologically or clinically according to the Chinese Society of Clinical Oncology guidelines for primary liver cancer 2019 version；
- •Aged ≥18 years and <80 years；
- •Live-GTV volume > 700ml;
- •BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning);
- •Estimated life expectancy should be more than 3 months;
- •Patients with lung and / or bone metastases can be enrolled if those metastases couldn't effect the patients' life and quality of life within 3 months;
- •Child-Pugh Score A5,A6,B7;
- •Liver function: ALT is less than 1.5 times of the upper limit of normal; ALT is less than 0.5 times of the upper limit of normal, AST can be less than 6 times of the upper limit of normal, excluding the elevation of AST caused by heart infarction; ALT is 0.5 to 1.5 times of the upper limit of normal, AST is less than 1.5 times of the upper limit of normal;
- •ECG examination showed no obvious abnormality, no obvious cardiac dysfunction;
- •Renal function: CRE and BUN were within 1.5 times of the upper limit of normal value;
- •Blood routine: HB ≥ 80g / L, ANC ≥ 1.0 × 109 / L, PLT ≥ 40 × 109 / L;
- •Coagulation function: no bleeding tendency;
- •Informed and voluntarily participated in the study and signed informed consent.
排除标准
- •Currently in the process of other clinical trials within recently four weeks;
- •Previous abdominal radiotherapy and liver transplantation;
- •Patients with severe chronic diseases of heart, kidney, liver and other important organs;
- •Pregnant or lactating women;
- •Suspected or indeed drug abusers, drug abusers and alcoholics;
- •Allergic to lenvatinib or other treatments.
- •Severe mental or nervous system disorders affecting informed consent and / or expression or observation of adverse reaction
结局指标
主要结局
MST
时间窗: 24 months
Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause
次要结局
- TTP(24 months)
- ORR(Assessment in 1 to 3 months after radiotherapy)
- Rate of III-IV grade adverse events(up to 24 months)
研究者
BO CHEN
Associate Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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