Efficacy Evaluation of 188Re-SSS Lipiodol Selective Internal Radiation Therapy of Non Operable Hepatocellular Carcinoma Patients, a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The objective response rate
研究概览
简要总结
The goal of this monocentric interventional study is to evaluate the efficacy, in terms of objective response rate, of the 188Re-SSS lipiodol SIRT in patients with non-operable HCC.
详细描述
This study is an open-labelled treatment administration study conducted with an exact one-stage one-arm study plan.
The study plans to included 35 patients and to treated 26 patients (take into account screen failures and SIRT contraindications).
The treatment is delivered by a one-day procedure leading to the injection of 188Re-SSS lipiodol. In details, the patient is hospitalized for one night. Two steps are performed while the patient is hospitalized: the pre-treatment simulation step and the treatment step itself.
After treatment, patients are followed until progression, new systemic or locoregional (in the same treatment area) antineoplastic therapy or death, within a maximum 24-month period following the SIRT.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG Performance Status 0-1
- •HCC with histological diagnosis or non-invasive diagnosis according to AASLD criteria
- •Non operable and not accessible to ablation therapy
- •At least one measurable lesion using mRECIST
- •Tumor involvement <50% of the liver
- •BCLC classification A to C
- •Compensated cirrhosis (Child Pugh A or B7), if cirrhosis present
- •Registration with a social security scheme
- •Written and informed consent of the patient or his/her legal representative
排除标准
- •Inadequate hematological, hepatic, renal, thyroid and coagulation functions:
- •Hemoglobin < 8,5 g/dl
- •Granulocytes < 1500/mm3
- •Platelets< 50 000 /mm3
- •Bilirubin level ≥ 35 mol/l
- •Transaminases > 6 UNL
- •Creatinine > 1,5 UNL
- •TSH < 0,2 µUI/L
- •Chronic respiratory insufficiency history
- •Known hemophilia with exophytic tumor > 1 cm
- •Extra-hepatic metastasis except hilum node < 2 cm
- •Lung shunt >20% evaluated with 99mTc albumin macroaggregate (MAA)
- •Poor tumor targeting with 99mTc albumin macroaggregate (MAA)
- •Previous SIRT
- •Previous systemic treatment within 4 weeks before radioembolization
- •More than 2 previous TACE (or embolization), in the area to be treated
- •Other neoplasia except if complete remission from at least one year
- •Contraindication related to the technique, in particular severe arterial pathology of the lower limbs or the aorta contraindicating or making difficult an arteriography by femoral approach
- •Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 1 month after the end of the treatment
- •Minors, individual deprived of liberty, or under any kind of guardianship or trusteeship.
- •Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.
研究组 & 干预措施
188Re-SSS lipiodol SIRT
Patients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT).
干预措施: Selective Internal Radiation Therapy with 188Re-SSS lipiodol (Combination Product)
结局指标
主要结局
The objective response rate
时间窗: through study completion, an average of 4 year
Defined as the best overall response occurring within 6 months' post 188Re-SSS lipiodol injection according to the modified RECIST criteria for hepatocellular carcinoma
次要结局
未报告次要终点