Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The absorbed radiation dose of tumor and normal organs
研究概览
简要总结
The purpose of this study is to evaluate the retention in tumour and distribution behavior of [Lu-177]-Catalase after intratumoral injection,and preliminary evaluation the efficacy and safety of [Lu-177]-Catalase.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At day1, patients who meet the eligibility requirements will be intratumoral injection the [Lu-177]-Catalase.The efficacy evaluation will be conducted at one month p.i., whether to continue intratumoral injection the [Lu-177]-Catalase, depending on the patient's efficacy and safety results.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, aged 18-70 years; ECOG score 0 or 1;
- •Patients with advanced malignant tumors, such as liver cancer, ovarian cancer, prostate cancer, and so on, clearly diagnosed by pathology and/or cytology;
- •Patients with advanced solid tumors who have failed or cannot tolerate standard treatment;
- •Expected survival of more than 3 months;
- •According to the solid tumor efficacy evaluation criteria , the patient had at least one measurable or evaluable tumor lesion with the longest diameter ≥10 mm at baseline (in the case of lymph nodes, the short diameter ≥15 mm). This lesion is suitable for intratumoral injection (the length of the lesion is at least 1 cm or equal).
- •Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC≥4.0×109L or neutrophil ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L; PT or APTT≤1.5ULN; Liver and kidney function: T-Bil≤1.5×ULT(upper limit of normal),ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis); BUN≤1.5×ULT, SCr≤1.5×ULT;
- •Women must use effective contraception during the study period and for 6 months after the study (effective contraception means sterilization, intrauterine hormone devices, condoms, contraceptives/pills, abstinence or partner vasectomy, etc.); Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period;
- •Can understand and voluntarily sign informed consent, compliance is good
排除标准
- •Severe abnormal liver and kidney function;
- •Pregnant, pregnant and lactating women;
- •Can not lie flat for half an hour;
- •Refuse to join the clinical investigator;
- •Suffering from claustrophobia or other mental illness;
- •Other conditions deemed unsuitable for participation in the trial by the investigator
研究组 & 干预措施
[ Lu-177]-Catalase
Participants received [ Lu-177]-Catalase intratumoral injection
干预措施: [ Lu-177]-Catalase (Drug)
结局指标
主要结局
The absorbed radiation dose of tumor and normal organs
时间窗: From first dose of study drug through 8 weeks post dose
Calculation of effective absorbed dose of tumor in situ injection
次要结局
- Preliminary efficacy of [ Lu-177]-Catalase based on tumor response(From first dose of study drug through 8 weeks post dose)