Phase I Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese hepatocellular carcinoma
详细描述
The purpose of this study is to determine the maximal tolerated dose (MTD) of carbon ion radiotherapy (CIRT) in the treatment of localized Chinese hepatocellular carcinoma with respective to toxicity and tumor control. Participants will be treated with CIRT with escalating dose regimens based on the tumor location to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 3 months after the completion of CIRT. Primary endpoint is toxicity, second endpoint is progression-free survival, overall survival and tumor response.
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
- 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
- •histologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis of HCC according to American association for the study of liver diseases （AASLD）-guidelines or clinical diagnosis criteria based on Alpha Fetoprotein （AFP), and radiological images proposed by Liver Cancer Society, Chinese Anti-Cancer Association;
- •no clinically distant metastasis;
- •Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 cm;
- •age ≥ 18 and <80 years of age;
- •Karnofsky Performance Score ≥ 70;
- •No previous invasive cancer (within 5 years before the HCC diagnosis)except for skin non-melanoma cancer or non muscle invasive bladder cancer; Ability to understand character and individual consequences of the clinical trial;
- •Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;
排除标准
- •Distant metastasis (M1);
- •maximal tumor size is more than 12 cm;
- •tumor invading adjacent gastrointestine (T4);
- •Child push score B or C;
- •Previous hepatic radiotherapy;
- •Severe systemic disorders;
- •Previous malignancy (within 5 years) except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer;
- •Non conformity of the radiotherapy dose distribution when compared to the dose constraints;
- •Psychiatric disorders or any other condition that can make unreliable the informed consent;
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Time interval from the start of CIRT to 3 months after the completion of CIRT
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- Overall survival of all patients(From the diagnosis of localized hepatocellular carcinoma, a median of 2 years)
- Progression-free survival of all patients(From the diagnosis of localized hepatocellular carcinoma, a median of 2 years)
- Number of participants with tumor response as assessed by RECIST 1.1(Time interval from the start of CIRT to 3 months after the completion of CIRT)
研究者
Guoliang Jiang
Director the committee of clinical technique
Shanghai Proton and Heavy Ion Center