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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The P. vivax infected blood will be confirmed to follow the national standard of blood donation to ensure that only P. vivax is included, excluding the presence of P. falciparum. Exclude other infectious diseases according to the test of national standard of blood donation.
Plasmodiun vivax
Guangzhou, Guangdong, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by NCI CTCAE 4.0
Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.
Time frame: 2 years
Progression free survival (PFS)
Progression free survival (PFS): Starting from treatment until the disease progression is first found or the time of any cause of death (disease progression refers to tumor growth, or metastasis of primary tumor, or discovery of new lesions).
Time frame: 2 years
Overall survival
The time starting from the treatment to death of whatever causes (when subjects have lost for follow-up before death, the last follow-up time will be calculated as the time of death).
Time frame: 2 years
Tumor marker level
The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.
Time frame: 2 years
Objective response rate (ORR)
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
Time frame: 2 years
the Score of Quality of life
Patients are regularly filled with QLQ-C30 (cancer patient quality of life scale) to assess the quality of life of the patients.
Time frame: 2 years
1 year of survival rate
The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated \* 100%.
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Time frame: 2 years
2 year of survival rate
The number of cancer cases remaining after 2 years of treatment / the total number of cancer cases treated \* 100%.
Time frame: 2 years
Immunological index
Detection of absolute number of immune cells(such as CD3+CD4+、CD3+CD8+ and so on)in peripheral blood by flow cytometry.
Time frame: 2 years