NSCLC
Conditions
Interventions
Experimental group:Blood-stage infection of P. vivax
Sponsors
The Fist Affiliated Hospital, Guangzhou Medical University, China
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years, male or female; 2. Unresectable stage III or IV non-small cell lung cancer, diagnosed by histological and radiological findings (UICC, Seventh Ed.), and of any histological subtype. Cancer staging during the initial diagnosis must be confirmed by radiographic findings (CT and/or MRI and/or PET-CT); 3. During study treatment, the patient should not receive other treatments, including chemotherapy, radiotherapy, targeted therapy, other biological therapy, physical therapy, traditional Chinese medicine, and so on 4. More than four weeks since the end of targeted therapy, or radiotherapy and chemotherapy (concurrent or sequential) 5. After the initial radiotherapy and chemotherapy, the objective response time is 16 weeks; 7. ECGO score of 0 or 1; 8. PLT >=100×10^9/L, WBC>=4×10^9/L, and HGB >=100g/L; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.); 9. The patient is willing to receive Plasmodium immunotherapy and is able to sign the informed consent; 10. For female patients: the result of a pregnancy test must be negative at screening. All subjects must consent to use birth control methods during treatment and for two months after discharge; 11. The subject is willing to follow the in-hospital exam and treatment and follow-up schedule; 12. The patient can return for regular scheduled follow-up visits during the 2-year follow-up period; 13. The subject agrees that the investigators may report and publish the results of this clinical study.
Exclusion criteria
Exclusion criteria: 1. Total 2.5 x ULN, AST > 2.5 x ULN, bilirubin > 1.5 x ULN; 9. Renal impairment: serum creatinine >=1.5 x ULN; 10. Patients with chronic heart disease, primarily those with recent (within a year) myocardial infarction, serious arrhythmias, heart failure, or aortic aneurysm; 11. Patients with splenectomy or splenomegaly; 12. Pregnant and nursing women; 13. Patients who have participated in other clinical studies during the previous three months; 14. Any condition that makes the subject ineligible to participate (in the opinion of the investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safty;Objective response rate;Quality of life;Performance Status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival; Regional progression free survival;Overall survival;Time to progression; | — |
Countries
China
Contacts
Public ContactMing Ou-Yang
the First Affiliated Hospital, Guangzhou Medical University, China
Outcome results
None listed