[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CAS Lamvac Biotech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100375216","phase-1-plasmodium-immunotherapy-for-advanced-malignant-solid-tumors-100375216",false,"NCT04165590","Plasmodium Immunotherapy for Advanced Malignant Solid Tumors","Clinical Study of Plasmodium Immunotherapy for Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Aged 18-70 years male or female.\n2. Patients with advanced maligant solid tumors in lung, liver, prostate, ovary, brain, thyroid and colorectum, etc.\n3. Patients with primary central nervous system (CNS) tumor or brain metastases from solid tumors, comply with the following standards can participate in this study: Up to the clinical trial screening period, the imageological examination provides progression-free evidence for at least 3 months, blood brain barrier has not been damaged or is already recovered from the former treatment (surgery or radiotherapy) injury, without intracranial hemorrhage or myelorrhagia history, without metastases to the brain stem, midbrain, pons, medulla oblongata or eye subsidiary organs within 10 mm area (the optic nerve and optic chiasma).\n4. The patients have measurable tumors based on the criterion of RECIST1.1.\n5. Tumor classification should be determined by histopathology and pathological report should be provided. If tumor tissue is available, before participating in the trail, the research center need to obtain the paraffin blocks or at least 6 unstained sections of the tumor tissue and the relevant pathological reports. If the above tumor tissue samples are not available, samples of any kind (such as fine needle aspiration biopsy samples, cell mass samples (such as pleural, peritoneal effusion samples and lavage samples) are acceptable. If tumor tissue is not available, patients are still eligible for the study.\n6. For the patients who previously received one or more of the following therapies, the interval time of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 28 days for patients who had received chemotherapy or radiotherapy; at least 5 half-life time for patients who had received targeted drug therapy (the half-life of targeted drug is according to the drug instructions).\n7. ECGO score is 0 to 2, and euphagia.\n8. Expected survival ≥ 3 months.\n9. WBC≥3× 10\\^9\u002FL, PLT ≥ 100× 10\\^9\u002FL, HGB ≥ 100 g\u002FL, and albumin ≥ 30 g\u002FL, no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.).\n10. Patients with gastrointestinal bleeding, hemoptysis or other chronic bleeding symptoms were cured before enrollment.\n11. Patients with no severe dysfunction of cardiopulmonary, liver and kidney function (child-push grading of liver function A or B, Cr≤ 1.5 x ULN).\n12. Patient will be able to understand and sign informed consent.\n13. According to the researcher's judgment, the patient's compliance could meet the needs of follow-up.\n\nExclusion Criteria:\n\n1. Nasopharyngeal cancer, head and neck tumors.\n2. HPV positive patients with advanced malignant solid tumors in cervical, anal, vulvar, vaginal and penile.\n3. Pancreatic cancer patients.\n4. Small cell lung cancer patients.\n5. Patients with severe hemoglobin disease or severe G6PD deficiency.\n6. Patients with splenectomy or splenomegaly.\n7. Patients with drug addiction or alcohol dependence.\n8. Have not yet been washed out from the previous therapeutic effects, except the following: the bisphosphonates used for bone metastasis or osteoporosis.\n9. Uncontrolled pleural effusion, pericardial effusion or ascites.\n10. Tumor-related pain that are uncontrollable.\n11. Active malignant tumor metastasis of CNS (progression or controlling the symptoms with anticonvulsants or corticosteroids ).\n12. Patients with significant immunodeficiency detection ( CD4+T cell absolute count \\\u003C200 \u002Ful)\n13. With the following diseases or conditions: 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.\n14. According to the principal investigator's judgment, any other diseases, metabolic disorders, abnormal results of clinical laboratory tests or physical examination, the diseases that leading to usage of the prohibited drugs, influencing the results reliability, putting patients in high risk.\n15. Have undergone major surgery within 4 weeks of the screening period, or plan to undergo major surgery during the study period, PICC catheter and central venous catheter implantation are excluded.\n16. Received any antineoplastic drugs, immune cells, antibodies, or vaccines within five drug half-life (not sure the half-life, will be subject to two weeks) during the screening period.\n17. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation.\n18. Receiving any other anti-tumor treatment at the same time.\n19. Lung function is seriously damaged, the MNW \\\u003C39% or can't get out of bed, still feel short of breath when resting.\n20. Rough cough, dyspnea, without normal diet or difficult to cooperate.\n21. Poor body condition, the researchers assess that the patients can't tolerate the Plasmodium immunotherapy.\n22. Pregnant or lactating women.\n23. Patients that are unable to comply with the research and follow-up procedure.\n24. Any case that the researchers believe that the patient does not suit for this clinical study.","ALL","18 Years","70 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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.\n\nThe treatment will last 5-10 weeks from the day of successful infection and will be terminated by antimalarial drugs.",[28],"Advanced Malignant Solid Tumor",[30,31,32],"advanced malignant solid tumor","Plasmodium immunotherapy","Plasmodiun vivax","RECRUITING","2024-02-17",{"date":36,"type":37},"2024-02-20","ACTUAL",{"date":39,"type":37},"2019-10-24",{"date":41,"type":21},"2026-10-31",{"name":43,"class":44},"CAS Lamvac Biotech Co., Ltd.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100322201","phase-1-plasmodium-immunotherapy-for-breast-and-liver-cancers-100322201","NCT03474822","Plasmodium Immunotherapy for Breast and Liver Cancers","Clinical Study of Plasmodium Immunotherapy for Advanced Breast Cancers and Advanced Liver Cancers","Inclusion Criteria:\n\n* 18-70 years of age, male or female.\n* Patients with advanced breast cancer and advanced liver cancer confirmed by histopathology and imaging; and imaging lesions of the tumor are clear and measurable.\n* Previously received at least one standard therapy.\n* The time interval of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 1 months for patients who had received 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).\n* ECGO score of 0 or 1;\n* Expected survival ≥ 6 months;\n* PLT ≥100× 10\\^9\u002FL, NE ≥ 1.5 × 10\\^9\u002FL, and HGB ≥ 100 g\u002FL; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.).\n* 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);\n* Patient compliance meets the need for follow-up;\n* The subjects are able to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Patients with severe hemoglobin disease or severe G6PD deficiency;\n* Patients with splenectomy or splenomegaly;\n* Patients with drug addiction or alcohol dependence;\n* With the following diseases or conditions: 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.\n* Accept any other anti-tumor treatment at the same time.\n* Patients with significantly lower immune function than those in the normal population.\n* Lung function is seriously damaged, the MNW \\\u003C39% or can't get out of bed, still feel short of breath when resting.\n* Advanced liver cancer patients with severe varicose vein in the esophagus.\n* Rough cough, dyspnea, without normal diet or difficult to cooperate.\n* Poor body condition, the researchers assess that the patients can't tolerate the immune therapy.\n* Pregnant or lactating women.\n* Women of childbearing age with positive result for pregnancy tests.\n* Any case that researchers believe that the patient does not suit for this clinical study.",{"count":20,"type":21},[24,25],"The purpose of this study is to evaluate the safety and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced breast cancers and advanced liver cancers.The treatment will last 4-6 weeks from the day of successful infection and will be terminated by antimalarial drugs.",[57,58],"Advanced Breast Cancer","Advanced Liver Cancer",[60,61,31,32],"Advanced breast cancer","advanced liver cancer",{"date":36,"type":37},{"date":64,"type":37},"2018-08-10",{"date":66,"type":21},"2026-06-30",{"name":43,"class":44},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":45},"100314627","phase-1-plasmodium-immunotherapy-for-advanced-cancers-100314627","NCT03375983","Plasmodium Immunotherapy for Advanced Cancers","Clinical Study of Plasmodium Immunotherapy for Advanced Cancers","Inclusion Criteria:\n\n* 18-70 years of age, male or female.\n* 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).\n* 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);\n* All the patients who have not received surgery, radiotherapy, chemotherapy or targeted drug therapy and refuse to accept the above treatments must meet all the remaining requirements that listed in the inclusion criteria;\n* ECGO score of 0 or 1;\n* Expected survival ≥ 6 months;\n* PLT ≥100× 10\\^9\u002FL, NE ≥ 1.5 × 10\\^9\u002FL, and HGB ≥ 100 g\u002FL; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.);\n* 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);\n* Patient compliance meets the need for follow-up;\n* The subjects are able to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Patients with severe hemoglobin disease or severe G6PD deficiency;\n* Patients with splenectomy or splenomegaly;\n* Patients with drug addiction or alcohol dependence;\n* 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;\n* Accept any other anti-tumor treatment at the same time;\n* Patients with significantly lower immune function than those in the normal population;\n* Lung function is seriously damaged, the MNW \\\u003C39% or can't get out of bed, still feel short of breath when resting;\n* Rough cough, dyspnea, without normal diet or difficult to cooperate;\n* Poor body condition, the researchers assess that the patients can't tolerate the immune therapy;\n* Pregnant or lactating women;\n* Women of childbearing age with positive result for pregnancy tests;\n* Any condition that makes the subject ineligible to participate (in the opinion of the investigator).",{"count":76,"type":21},20,[24,25],"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.",[80],"Advanced Cancers",[82,31,32],"Advanced cancer",{"date":36,"type":37},{"date":85,"type":37},"2017-11-23",{"date":87,"type":21},"2026-07-31",{"name":43,"class":44},""]