A Prospective Phase II Single-institution Trial of Carbon-ion Radiotherapy Combined With Granulocyte-macrophage Colony-stimulating Factor for the Treatment of Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Progression-free survival of all patients
研究概览
简要总结
The aim of this research project is to assess the efficacy and toxicity of hypofractionated carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for the treatment of hepatocellular carcinoma
详细描述
Golden E.B. et al.in 2015 reported that localized radiotherapy granulocyte-macrophage colony-stimulating factor (GM-CSF) produced objective abscopal responses in solid tumor with metastasises. We hypothesize that hypofractionated carbon-ion radiotherapy combining granulocyte-macrophage colony-stimulating factor (GM-CSF) might improve the clinical response rate and progression-free survival (PFS) in hepatocellular carcinoma. The primary endpoint of the current phase II trial is progression-free survival rate at 2 years, secondary endpoints are overall survival, safety and toxicity.
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
- •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;
- •the tumor is away from gastro-intestinal (GI) tract (>1cm);
- •Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 10 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 10 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;
研究组 & 干预措施
carbon-ion radiotherapy with GM-CSF
Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gray(Gy) [relative biological effectiveness (RBE)] in 5 fractions for intrahepatic cases away from gastro-intestinal (GI) tract (>1cm) with concurrent GM-CSF 125ug/m2/d, subcutaneous injection d1-28;
干预措施: carbon-ion radiotherapy (Radiation)
结局指标
主要结局
Progression-free survival of all patients
时间窗: 2 year
Time in months measured from treatment initiation until the date of progression or the date of last follow-up.
次要结局
- Overall Survival(2 year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Time interval from the start of carbon-ion radiotherapy to 3 months after the completion of carbon-ion radiotherapy])
- Objective responses rate(3 months)
研究者
Guoliang Jiang
Director the committee of clinical technique
Shanghai Proton and Heavy Ion Center