Clinical trial · Interventional
Plasmodium Immunotherapy for Lung Cancer
Clinical Study of Plasmodium Immunotherapy for Advanced Non-small Cell Lung Cancer
NCT02786589CI-TRIAL-00067359unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to evaluate the safety and the effectiveness of Plasmodium immunotherapy (blood-stage infection of Plasmodium vivax) for advanced non-small cell lung cancer.The treatment will last 3-6 months from the day of successful infection and will be terminated by antimalarial drugs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood-stage infection of P. vivax | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blood-stage infection of P. vivax
- description
- This is a single arm study that enrolls 30 patients to receive Plasmodium immunotherapy.
- interventionNames
- Biological: Blood-stage infection of P. vivax
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0
- timeFrame
- 2 years
- description
- Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.
Secondary outcomes (9)
- measure
- Progression free survival(PFS)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18-70 years of age, male or female * 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) * 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 * At least 5 half-life of the targeted drug (the half- life calculation is based on the targeted drug instructions) since the end the targeted therapy;More than 12 weeks since the end of radiotherapy or chemotherapy (common or continuous) * Expected survival \> 16 weeks * ECGO score of 0 or 1 * PLT ≥100 × 10\^9/L, WBC ≥ 4 × 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 patient's peripheral blood immune cell count and immune function test are close to normal or normal, and the heart and lungs and kidneys are normal. * The patient is willing to receive Plasmodium immunotherapy and is able to sign the informed consent * 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 * The subject is willing to follow the in-hospital exam and treatment and follow-up schedule * The patient can return for regular scheduled follow-up visits during the 2-year follow-up period * The subject agrees that the investigators may report and publish the results of this clinical study Exclusion Criteria: * Total ≤ 4 weeks after surgical treatment or other forms of treatments * Active chronic lung diseases (hypoxemia due to bronchial asthma, tuberculosis, other conditions); lung metastatic tumor; other comorbid tumors * Patients with newly diagnosed brain metastasis (not including the previous brain metastatic lesion, which is not visible by image at the time of screening) * Patients with autoimmune disease or other immunodeficiency diseases * Patients taking long-term steroids or immunosuppressants * Patients with severe hemoglobin disease or severe G6PD deficiency * Patients with active or chronic symptomatic hepatitis * Patients with other serious complications such as severe hemoptysis and massive pleural and ascitic fluid * Liver impairment: ALT \> 2.5 x ULN, AST \> 2.5 x ULN, bilirubin \> 1.5 x ULN * Renal impairment: serum creatinine ≥ 1.5 x ULN * Patients with chronic heart disease, primarily those with recent (within a year) myocardial infarction, serious arrhythmias, heart failure, or aortic aneurysm * Patients with serious drug allergy * Patients with splenectomy or splenomegaly * Pregnant and nursing women * Patients who participating in other clinical trials at the same time or less than 12 weeks since withdraw from other clinical trials * Any condition that makes the subject ineligible to participate (in the opinion of the investigator)
References
Publications (1)
- RESULTChen L, He Z, Qin L, Li Q, Shi X, Zhao S, Chen L, Zhong N, Chen X. Antitumor effect of malaria parasite infection in a murine Lewis lung cancer model through induction of innate and adaptive immunity. PLoS One. 2011;6(9):e24407. doi: 10.1371/journal.pone.0024407. Epub 2011 Sep 9. PMID 21931708