The main purpose of this study is to evaluate the safety and effectiveness of Plasmodium immunotherapy in the treatment of advanced ovarian cancer. This study plans to enroll 30 patients with advanced ovarian cancer. Each patient is inoculated with Plasmodium vivax 1-5 × 10\^6, observe the time when the parasite is detected in the peripheral blood of the subjects after the inoculation of Plasmodium, the change of the parasite density in the peripheral blood of the whole treatment cycle and the control effect of the drug on the parasite density, the main clinical symptoms and signs, laboratory test indicators, immunological test indicators and changes in the quality of life. To evaluate the safety and tolerance of the subjects to Plasmodium immunotherapy, as well as the changes of tumor related indicators and immunological indicators.
Each subject who passed the screening is immunized with Plasmodium vivax 1-5 × 10\^6, observe the time when the parasite is detected in the peripheral blood of the subjects after inoculation, the change of the parasite density in the peripheral blood of the whole treatment cycle (about 6 weeks) and the control effect of the drug on the parasite density. The clinical symptoms and signs after treatment are mainly observed; Blood routine, blood biochemistry, blood coagulation, tumor markers and other laboratory test indicators change; Changes of cellular immunity and humoral immunity; Changes in quality of life. When Plasmodium infected erythrocytes among total erythrocytes (defined as the parasite density) ≥ 0.1% occurs during the test, artemisinin drugs should be used to control the parasite density below 0.1%, and symptomatic treatment should be carried out. The duration of Plasmodium immunotherapy for each subject is 6 weeks (time window, ± 1 day). The day the immunodynamic marker (Fim) is greater than baseline level is defined as the first day of Plasmodium immunotherapy. When Plasmodium immunotherapy lasts for 6 weeks (time window, ± 1 day), use antimalarial drugs to kill the parasite and terminate the treatment. After treatment, the patients are followed up for 2 years. We will carry out a follow-up visit once a month after the termination of Plasmodium infection according to the plan, and the follow-up visit in the first month, third month and sixth month is outpatient visit, which is ± 5 days in the first month and ± 7 days in the third month and sixth month respectively; Follow-up outpatient visit will be conducted every 3 months ± 10 days; The rest are telephone follow-up (once every 30 days ± 5). When the follow-up time overlaps with the previous outpatient follow-up time, no additional telephone follow-up will be conducted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Inoculation 1-5 × 10\^6 Plasmodium vivax once
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
Objective response rate(ORR)
The proportion of patients whose tumors shrink to a certain amount and remain for a certain time.
Time frame: 2 years
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
Disease control rate (DCR)
The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
Time frame: 2 years
1-year survival rate
The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated \* 100%.
Time frame: 1 years
2-year 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
Overall survival (OS)
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. The tumor markers include Carcinoembryonic antigen(CEA), Carbohydrate Antigen 125(CA125), human epididymis protein 4(HE4), alpha-fetal protein(AFP), neuron-specific enolase(NSE), Carbohydrate Antigen 199(CA199).
Time frame: 2 years
Incidence of adverse events (AE) and serious adverse events (SAE)
Any adverse medical event occurred in the subjects who participated in the clinical study and received Plasmodium immunotherapy.
Time frame: 2 years
Pain score
Patients are regularly evaluated with Visual Analog Scale for Pain. The minimum value is 0, and the maximum value is 10. The higher scores mean a worse outcome.
Time frame: 2 years
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