Plasmodium Immunotherapy for Advanced Cancers
Clinical Study of Plasmodium Immunotherapy for Advanced Cancers
CAS Lamvac Biotech Co., Ltd.
20 participants
Nov 23, 2017
INTERVENTIONAL
Summary
The purpose of this study is to evaluate the safety of Plasmodium immunotherapy and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced cancers.The treatment will last 3-6 months from the day of successful infection and will be terminated by antimalarial drugs.
Eligibility
Inclusion Criteria9
- -70 years of age, male or female.
- Patients with advanced cancer confirmed by histopathology and imaging; and imaging lesions of the tumor are clear and measurable, including but not limited to colon cancer, breast cancer, liver cancer, lung cancer, gastric cancer,sarcoma and other solid tumors (except for nasopharyngeal carcinoma, lymphatic cancer, cervical cancer and melanoma).
- The time interval of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 3 months for patients who had received chemotherapy (including interventional chemotherapy) or radiotherapy; at least 5 half-life for patients who had received targeted drug therapy (the half-life of targeted drug is according to the drug instructions);
- ECGO score of 0 or 1;
- Expected survival ≥ 6 months;
- PLT ≥100× 10\^9/L, NE ≥ 1.5 × 10\^9/L, and HGB ≥ 100 g/L; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.);
- The peripheral blood count of immune cells is close to normal or normal, the immune function test result is close to or at the level of normal population, and the function of heart, lung, liver and kidney are basically normal (the liver function classification of Child-push is A or B, Cr≤1.5×ULN);
- Patient compliance meets the need for follow-up;
- The subjects are able to understand and sign informed consent.
Exclusion Criteria12
- Patients with severe hemoglobin disease or severe G6PD deficiency;
- Patients with splenectomy or splenomegaly;
- Patients with drug addiction or alcohol dependence;
- With the following diseases or conditions: newly diagnosed with CNS metastasis ( excluding that the tumor lesions of the CNS has disappeared after treatment) and serious or uncontrolled systemic disease or any unstable systemic diseases (including but not limited to active infection, grade three hypertension, unstable angina, congestive heart failure, class III or IV heart disease, severe arrhythmia, liver and kidney dysfunction or metabolic disease), a clear history of neurological or psychiatric disorders, etc;
- Accept any other anti-tumor treatment at the same time;
- Patients with significantly lower immune function than those in the normal population;
- Lung function is seriously damaged, the MNW <39% or can't get out of bed, still feel short of breath when resting;
- Rough cough, dyspnea, without normal diet or difficult to cooperate;
- Poor body condition, the researchers assess that the patients can't tolerate the immune therapy;
- Pregnant or lactating women;
- Women of childbearing age with positive result for pregnancy tests;
- Any condition that makes the subject ineligible to participate (in the opinion of the investigator).
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03375983