The objective of this study is to evaluate the safety and the effectiveness of Plasmodium immunotherapy (blood-stage infection of Plasmodium vivax) for advanced non-small cell lung cancer.The treatment will last 3-6 months from the day of successful infection and will be terminated by antimalarial drugs.
In our study,30 patients with stage III/IV NSCLC will be enrolled to receive vaccination with an optimal concentration and amount of blood-stage P. vivax to observe the infection time, rate and cycle; principal clinical symptoms such as fever and anemia; heart, liver and kidney function; changes in spleen morphology and function, and dynamic changes in the function of peripheral immune cells. Moreover, the patient's tolerance to Plasmodium infection and changes in tumor-related parameters will be observed. The duration of the planned treatment is 3-6 months, and successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last at least 12 weeks from the day of finding the Plasmodium from peripheral blood and will be terminated by chloroquine phosphate or Artemisinin compound preparation or Artesunate injection. Each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1×10\^7 Plasmodium parasites. After vaccination, the onset and duration of peripheral parasitemia and the infection rate; principal clinical symptoms such as Chills, fever, pain (headache, joint pain, etc.), digestive tract reaction;peripheral hemogram changes;heart, liver and kidney function; changes in lung function, and dynamic changes in the function of peripheral immune cells will be observed. Moreover, the patient's tolerance to Plasmodium infection and changes in tumor-related parameters will be observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1×10\^7 Plasmodium parasites.And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples.The treatment will last at least 12 weeks from the day of finding the Plasmodium from peripheral blood and will be terminated by chloroquine phosphate or Artemisinin compound preparation or Artesunate injection.
The First Affiliated Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0
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 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(OS)
The time starting from the treatment to death of whatever causes (when subjects have lost to 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
Quality of life score
Patients are regularly with QLQ-C30(cancer patient quality of life scale)to assess the quality of life of the patients.
Time frame: 2 years
Time to progression(TTP)
The time starting from the research to tumor progression.
Time frame: 2 years
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1 year of survival rate
The number of cancer cases remaining after 1 year of treatment/the total number of cancer cases treated\*100%.
Time frame: 2 years
2 year of survival rate
The number of cancer cases remaining after 2 year 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 cytometry.
Time frame: 2 years