Plasmodium Immunotherapy for Breast and Liver Cancers
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|ClinicalTrials.gov Identifier: NCT03474822|
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : May 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer Advanced Liver Cancer||Biological: Blood-stage infection of P.vivax||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Plasmodium Immunotherapy for Advanced Breast Cancers and Advanced Liver Cancers|
|Actual Study Start Date :||August 10, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Blood-stage infection of P.vivax
This is a single arm study that plans to enroll 30 patients in each type cancer and each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10^7 Plasmodium parasites. The treatment will last 4-6 weeks from the day of successful infection and will be terminated by antimalarial drugs.
Biological: Blood-stage infection of P.vivax
The P. vivax infected blood will be confirmed to follow the national standard of blood donation to ensure that only P. vivax is included, excluding the presence of P. falciparum. Exclude other infectious diseases according to the test of national standard of blood donation.
- Number of participants with treatment-related adverse events as assessed by NCI CTCAE 4.0 [ Time Frame: 2 years ]Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.
- Progression free survival (PFS) [ 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).
- Overall survival [ Time Frame: 2 years ]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).
- Tumor marker level [ Time Frame: 2 years ]The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.
- Objective response rate (ORR) [ Time Frame: 2 years ]The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
- Quality of life [ Time Frame: 2 years ]Patients are regularly filled with QLQ-C30 (cancer patient quality of life scale) to assess the quality of life of the patients.
- 1 year of survival rate [ Time Frame: 2 years ]The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated * 100%.
- 2 year of survival rate [ Time Frame: 2 years ]The number of cancer cases remaining after 2 years of treatment / the total number of cancer cases treated * 100%.
- Immunological index [ Time Frame: 2 years ]Detection of absolute number of immune cells（such as CD3+CD4+、CD3+CD8+ and so on）in peripheral blood by flow cytometry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474822
|Contact: Qin Li, M.Dfirstname.lastname@example.org|
|Contact: Zhang Su Yi, M.Demail@example.com|
|Guangzhou, Guangdong, China, 510000|
|Contact: Zhang Su Yi, M.D 0086-20-82258805 firstname.lastname@example.org|
|Principal Investigator: Hou Jiang Hou, M.D|