The purpose of this study is: 1) to evaluate the effectiveness and extended safety of the Plasmodium immunotherapy for the advanced malignant solid tumors. 2) To explore the safe and effective course of the Plasmodium immunotherapy for the advanced malignant solid tumors. 3) To explore the possible indications of Plasmodium immunotherapy for advanced malignant solid tumors. The treatment will last 5-10 weeks from the day of successful infection and will be terminated by antimalarial drugs.
This study is planed to enroll 60 patients. Each patient will be vaccinated with 2 ml of P. vivax-infected red blood cells, containing approximately 0.1-1.0 × 10\^7 Plasmodium parasites. The treatment will last for 5-10 weeks from the day of successful infection. During the period of Plasmodium immunotherapy, doctor will use artesunate to control the P. vivax erythrocyte infection rate at a low level, so as to prevent the severe adverse event. After 5-10 weeks, parasitemia will be terminated by antimalarial drugs for ending the treatment of Plasmodium immunotherapy (the immunological treatment effect may persist after the termination of Plasmodium infection). After the treatment, patients will be followed up for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.1-1.0 × 10\^7 Plasmodium parasites.
Yunnan Kungang Hospital
Kunming, Yunnan, China
RECRUITINGProgression 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
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
Disease Control Rate
The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
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
Quality of life score
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
time of tumor progression
TTP is the time between the beginning of treatment and the onset of tumor progression.
Time frame: 2 years
Duration of disease control
Duration of disease control is the time from the first evaluation of the tumor as CR, PR or SD to the first evaluation as PD (progressive disease) or any cause of death.
Time frame: 2 years
pain score
Patients are regularly evluated with pain assessment scale
Time frame: 2 years