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Brief Title: Plasmodium Immunotherapy for Advanced Malignant Solid Tumors
Official Title: Clinical Study of Plasmodium Immunotherapy for Advanced Malignant Solid Tumors
Study ID: NCT04165590
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Yunnan Kungang Hospital, Kunming, Yunnan, China
Name: Hou Jianghou, Ph.D
Affiliation: Yunnan Kungang Hospital
Role: STUDY_DIRECTOR