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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood-stage infection of P.vivax | Experimental | This is a single arm study that is planed to enroll 60 patients with advanced malignant solid tumor and each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10^7 Plasmodium parasites. And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last 5-10 weeks from the day of successful infection and will be terminated by antimalarial drugs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmodium immunotherapy | Other | The patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.1-1.0 × 10^7 Plasmodium parasites. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor marker level | The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study. | 2 years |
| Disease Control Rate | The proportion of patients who had a best response rating of complete response, partial response, or stable disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Li, Ph.D | Contact | 0086-18802043960 | qin_li@cas-lamvac.com | |
| Huang Qiumei, M.D | Contact | 0086-20-82258809 | huang_qiumei@cas-lamvac.com |
| Name | Affiliation | Role |
|---|---|---|
| Hou Jianghou, Ph.D | Yunnan Kungang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunnan Kungang Hospital | Recruiting | Kunming | Yunnan | 650000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21931708 | Result | Chen L, He Z, Qin L, Li Q, Shi X, Zhao S, Chen L, Zhong N, Chen X. Antitumor effect of malaria parasite infection in a murine Lewis lung cancer model through induction of innate and adaptive immunity. PLoS One. 2011;6(9):e24407. doi: 10.1371/journal.pone.0024407. Epub 2011 Sep 9. | |
| 28228842 | Result | Qin L, Chen C, Chen L, Xue R, Ou-Yang M, Zhou C, Zhao S, He Z, Xia Y, He J, Liu P, Zhong N, Chen X. Worldwide malaria incidence and cancer mortality are inversely associated. Infect Agent Cancer. 2017 Feb 14;12:14. doi: 10.1186/s13027-017-0117-x. eCollection 2017. |
| Label | URL |
|---|---|
| Free full text. | View source |
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| 2 years |
| Immunological index | Detection of absolute number of immune cells(such as CD3+CD4+、CD3+CD8+ and so on)in peripheral blood by flow cytometry. | 2 years |
| Quality of life score | Patients are regularly filled with QLQ-C30 (cancer patient quality of life scale) to assess the quality of life of the patients. | 2 years |
| Overall survival | 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). | 2 years |
| 1 year of survival rate | The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated * 100%. | 2 years |
| 2 year of survival rate | The number of cancer cases remaining after 2 years of treatment / the total number of cancer cases treated * 100%. | 2 years |
| time of tumor progression | TTP is the time between the beginning of treatment and the onset of tumor progression. | 2 years |
| Duration of disease control | Duration of disease control is the time from the first evaluation of the tumor as CR, PR or SD to the first evaluation as PD (progressive disease) or any cause of death. | 2 years |
| pain score | Patients are regularly evluated with pain assessment scale | 2 years |
| 28650446 | Result | Yang Y, Liu Q, Lu J, Adah D, Yu S, Zhao S, Yao Y, Qin L, Qin L, Chen X. Exosomes from Plasmodium-infected hosts inhibit tumor angiogenesis in a murine Lewis lung cancer model. Oncogenesis. 2017 Jun 26;6(6):e351. doi: 10.1038/oncsis.2017.52. |
| 28445973 | Result | Liu Q, Yang Y, Tan X, Tao Z, Adah D, Yu S, Lu J, Zhao S, Qin L, Qin L, Chen X. Plasmodium parasite as an effective hepatocellular carcinoma antigen glypican-3 delivery vector. Oncotarget. 2017 Apr 11;8(15):24785-24796. doi: 10.18632/oncotarget.15806. |
| 30979375 | Result | Adah D, Yang Y, Liu Q, Gadidasu K, Tao Z, Yu S, Dai L, Li X, Zhao S, Qin L, Qin L, Chen X. Plasmodium infection inhibits the expansion and activation of MDSCs and Tregs in the tumor microenvironment in a murine Lewis lung cancer model. Cell Commun Signal. 2019 Apr 12;17(1):32. doi: 10.1186/s12964-019-0342-6. |
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