Clinical Study of Plasmodium Immunotherapy for Advanced Breast Cancers and Advanced Liver Cancers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by NCI CTCAE 4.0
研究概览
简要总结
The purpose of this study is to evaluate the safety and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced breast cancers and advanced liver cancers.The treatment will last 4-6 weeks from the day of successful infection and will be terminated by antimalarial drugs.
详细描述
This study is to enroll 30 patients in each type of cancer. Each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10^7 Plasmodium parasites and be observed for the exact infection time, parasitemia condition and infection course; principal clinical symptoms such as fever; gastrointestinal reaction; peripheral blood parameters; the changes in heart, lung, liver and kidney function. Preliminarily observe the changes in the primary and metastatic lesions of the cancer, the tolerance of patients to Plasmodium infection, changes in tumor-related parameters and immunological related parameters.The rate of the erythrocytes infected by plasmodium is controlled below 0.01% by using Artemisinin during the course, and clinical treatment is conduced according to the microscopic examination to ensure that no serious complications occurs.The duration of the planned treatment of each subject is 4-6 weeks. The time of the treatment course is based on vaccination with P.vivax-infected red blood cells. After 4-6 weeks, parasitemia will be terminated by antimalarial drugs for terminating the treatment of Plasmodium immunotherapy (the immunological treatment effect may persist after the termination of Plasmodium infection), and then the patients are followed up for 2 years.
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
- •18-70 years of age, male or female.
- •Patients with advanced breast cancer and advanced liver cancer confirmed by histopathology and imaging; and imaging lesions of the tumor are clear and measurable.
- •Previously received at least one standard therapy.
- •The time interval of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 1 months for patients who had received chemotherapy or radiotherapy; at least 5 half-life for patients who had received targeted drug therapy (the half-life of targeted drug is according to the drug instructions).
- •ECGO score of 0 or 1;
- •Expected survival ≥ 6 months;
- •PLT ≥100× 10^9/L, NE ≥ 1.5 × 10^9/L, and HGB ≥ 100 g/L; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.).
- •The peripheral blood count of immune cells is close to normal or normal, the immune function test result is close to or at the level of normal population, and the function of heart, lung, liver and kidney are basically normal (the liver function classification of Child-push is A or B, Cr≤1.5×ULN);
- •Patient compliance meets the need for follow-up;
- •The subjects are able to understand and sign informed consent.
排除标准
- •Patients with severe hemoglobin disease or severe G6PD deficiency;
- •Patients with splenectomy or splenomegaly;
- •Patients with drug addiction or alcohol dependence;
- •With the following diseases or conditions: serious or uncontrolled systemic disease or any unstable systemic diseases (including but not limited to active infection, grade three hypertension, unstable angina, congestive heart failure, class III or IV heart disease, severe arrhythmia, liver and kidney dysfunction or metabolic disease), a clear history of neurological or psychiatric disorders, etc.
- •Accept any other anti-tumor treatment at the same time.
- •Patients with significantly lower immune function than those in the normal population.
- •Lung function is seriously damaged, the MNW <39% or can't get out of bed, still feel short of breath when resting.
- •Advanced liver cancer patients with severe varicose vein in the esophagus.
- •Rough cough, dyspnea, without normal diet or difficult to cooperate.
- •Poor body condition, the researchers assess that the patients can't tolerate the immune therapy.
- •Pregnant or lactating women.
- •Women of childbearing age with positive result for pregnancy tests.
- •Any case that researchers believe that the patient does not suit for this clinical study.
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by NCI CTCAE 4.0
时间窗: 2 years
Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.
次要结局
- Objective response rate (ORR)(2 years)
- the Score of Quality of life(2 years)
- 1 year of survival rate(2 years)
- Progression free survival (PFS)(2 years)
- Overall survival(2 years)
- Tumor marker level(2 years)
- 2 year of survival rate(2 years)
- Immunological index(2 years)