Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Advanced Breast Cancer
  • Advanced Liver Cancer
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

This study is to enroll 30 patients in each type of cancer. Each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10^7 Plasmodium parasites and be observed for the exact infection time, parasitemia condition and infection course; principal clinical ...

This study is to enroll 30 patients in each type of cancer. Each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10^7 Plasmodium parasites and be observed for the exact infection time, parasitemia condition and infection course; principal clinical symptoms such as fever; gastrointestinal reaction; peripheral blood parameters; the changes in heart, lung, liver and kidney function. Preliminarily observe the changes in the primary and metastatic lesions of the cancer, the tolerance of patients to Plasmodium infection, changes in tumor-related parameters and immunological related parameters.The rate of the erythrocytes infected by plasmodium is controlled below 0.01% by using Artemisinin during the course, and clinical treatment is conduced according to the microscopic examination to ensure that no serious complications occurs.The duration of the planned treatment of each subject is 4-6 weeks. The time of the treatment course is based on vaccination with P.vivax-infected red blood cells. After 4-6 weeks, parasitemia will be terminated by antimalarial drugs for terminating the treatment of Plasmodium immunotherapy (the immunological treatment effect may persist after the termination of Plasmodium infection), and then the patients are followed up for 2 years.

Tracking Information

NCT #
NCT03474822
Collaborators
Not Provided
Investigators
Not Provided