Plasmodium Immunotherapy for Advanced Cancers

Launched by CAS LAMVAC BIOTECH CO., LTD. · Dec 15, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Plasmodium immunotherapy for people with advanced cancers. The main goal is to see if this treatment is safe and to get an early idea of how effective it might be. If you are between 18 and 70 years old and have a confirmed advanced cancer, such as colon, breast, or lung cancer, you might be eligible to participate. It’s important that you haven't had significant cancer treatments like chemotherapy or radiation in the last few months, and that you feel well enough to tolerate the study.

If you join the trial, you will receive the Plasmodium treatment for about 3 to 6 months, after which you will take medication to stop the treatment. Throughout this time, your health will be closely monitored. This trial is currently looking for participants, so if you or someone you know fits the eligibility criteria and is interested, it may be a good opportunity to explore a new potential treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-70 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);
• • 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;
• • 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 Criteria:
• • 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).