Using Plasmodium immunotherapy to treat advanced lung cancer
Clinical Study of Plasmodium Immunotherapy for Advanced Non-small Cell Lung Cancer
This study is testing if a new immunotherapy using a malaria parasite can help people with advanced lung cancer improve their health and fight the disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | State Key Laboratory of Respiratory Disease Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT02786589 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of Plasmodium immunotherapy, specifically using blood-stage infection of Plasmodium vivax, for patients with advanced non-small cell lung cancer (NSCLC). A total of 30 patients with stage III/IV NSCLC will receive vaccinations with P. vivax-infected red blood cells, and their response will be monitored over a treatment period of 3-6 months. Key observations will include infection rates, clinical symptoms, and changes in immune cell function, as well as tumor-related parameters. The treatment will be concluded with antimalarial drugs once successful infection is confirmed.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with unresectable stage III or IV non-small cell lung cancer.
Not a fit: Patients currently receiving other cancer treatments or with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel immunotherapy option for patients with advanced lung cancer.
How similar studies have performed: While the use of Plasmodium vivax in cancer treatment is novel, other immunotherapy approaches have shown promise in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital, Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Ming Ou-Yang, M.D. — The First Affiliated Hospital, Guangzhou Medical University，China
- Study coordinator: Chengzhi Zhou, M.D.
- Phone: 0086-20-83062888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.