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.
18-80 years old(including the threshold), female;
The patients with ovarian cancer, who has been diagnosed by histopathological examination, can provide pathological reports, and is classified as stage III or stage IV according to the American Joint Committee on Cancer (AJCC) ovarian cancer staging version 8 (2017);
Platinum-resistant patient who has received at least the first line of platinum-containing standard chemotherapy (refer to China's Guidelines for the Diagnosis and Treatment of Ovarian Cancer (2022)) in the past, and have been evaluated as disease progression by objective imaging;
According to the evaluation standard of solid tumor efficacy RECIST 1.1, the therapeutic effect can be evaluated if there is ≥ 1 measurable lesion or continuous positive tumor marker;
Have received any investigational drug within 4 weeks before the first inoculation of Plasmodium parasite, or have participated in another clinical study at the same time (except that the subjects have participated in the observational and non-interventive clinical study, or are in the follow-up period of the intervention clinical study);
Immunodeficiency diseases, including HIV infection, other acquired and congenital immunodeficiency diseases;
Coagulation dysfunction, or acute or chronic hemorrhagic disease;
Have received other anti-tumor treatment in the past, and the period from the termination of treatment to the screening is less than 14 days or 5 half-lives (whichever occurs first);
Single group
Plasmodium immunotherapy
Biological/VaccineInoculation 1-5 × 10\^6 Plasmodium vivax once
Objective response rate（ORR）
The proportion of patients whose tumors shrink to a certain amount and remain for a certain time.
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).
Disease control rate (DCR)
The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
1-year survival rate
The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated \* 100%.
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.
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.
Immunological indicators
Detection of absolute number of immune cells（such as CD3+CD4+、CD3+CD8+ and so on）in peripheral blood by flow cytometry.
Click on the lead sponsor to view all of their trials.
CAS Lamvac (Guangzhou) Biomedical Technology Co., Ltd.
Lead sponsor
The Third Affiliated Hospital of Southern Medical University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
