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Clinical study of Plasmodium immunotherapy for advanced cancers

Clinical study of Plasmodium immunotherapy for advanced cancers

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17013921
Enrollment
Unknown
Registered
2017-12-14
Start date
2017-08-01
Completion date
Unknown
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced cancer

Interventions

Experimental group:Blood-stage infection of P.vivax

Sponsors

CAS Lamvac Biotech Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18-70 years of age, male or female. 2. 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); 3. 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 instruction); 4. All the patients who have not received surgeryradiotherapychemotherapy or target drugs and refused to accept the above treatments must meet all the remaining requirements that listed in the inclusion criteria; 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.); 5. The peripheral blood count of immune cells is close to normal or normal, the immune function test result is close to or reaches the level of normal population, and the function of heart, lung, liver and kidney is basically normal (the liver function classification of Child-push is A or B, Cr=1.5×ULN); 6. Patient compliance meets the need for follow-up; 7. The subjects are able to understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe hemoglobin disease or severe G6PD deficiency; 2. Patients with splenectomy or splenomegaly; 3. Patients with drug addiction or alcohol dependence; 4. 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; 5. Accept any other anti-tumor treatment at the same time; 6. 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; 7. Rough cough, dyspnea, without normal diet or difficult to cooperate; 8. Poor body condition, the researchers assess that the patients can't tolerate the immune therapy; 9. Pregnant or lactating women; 10. Women of childbearing age with positive result for pregnancy tests; 11. Any condition that makes the subject ineligible to participate (in the opinion of the investigator).

Design outcomes

Primary

MeasureTime frame
Safty;Effectiveness;

Secondary

MeasureTime frame
Overall survival;Tumor marker level;Quality of life;1 year of survival rate;2 years of survival rate;Objective response rate;

Countries

China

Contacts

Public ContactXiaoping Chen

CAS Lamvac Biotech Co., Ltd

njlf@cas-lamvac.com+86 020 82258805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026