Actively Recruiting
Personalized Tumor Neoantigen-loaded Dendritic Cell Vaccine Combined with PD-1 Inhibitor and Radiotherapy for Advanced Non-Small Cell Lung Cancer Progressed After Second-line Treatment
Led by The First Affiliated Hospital of Nanchang University · Updated on 2024-12-30
10
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment approach for patients with advanced non-small cell lung cancer (NSCLC) who have progressed after second-line therapy. The study focuses on assessing the effectiveness and safety of a personalized tumor neoantigen-loaded dendritic cell (DC) vaccine combined with PD-1 inhibitor therapy and radiotherapy. This phase 2 study aims to observe key outcomes including objective response rate, disease control rate, adverse events, progression-free survival, and overall survival. The treatment involves personalized radiotherapy followed by PD-1 inhibitor injections every three weeks and a series of ten subcutaneous injections of the personalized DC vaccine over 21 weeks. The vaccine treatment includes a primary phase with six doses administered weekly and biweekly, and a boost phase with four doses given every three weeks. Radiotherapy is completed before starting the vaccine and PD-1 inhibitor treatments, with dosing schedules tailored by the treating physician. Participants will undergo regular follow-up visits every six weeks until study completion, involving physical exams, imaging scans (CT/MRI, X-ray), laboratory tests, and performance assessments. Blood samples will be collected for vaccine preparation and ongoing monitoring. The study tracks response and safety outcomes over approximately 32 weeks, including evaluations of treatment response, disease control, and adverse events.
CONDITIONS
Official Title
Neoantigen-loaded DC Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed advanced NSCLC who require radiotherapy for metastatic lesions
- At least one measurable lesion
- Aged 18 to 70, any gender
- Disease progression after standard second-line therapy and more than 2 weeks since last antitumor treatment
- Expected survival of at least 3 months
- ECOG performance status of 0 or 1
- Female participants of childbearing age must have a negative pregnancy test and use effective contraception with no plans for pregnancy within 6 months
- Ability to complete all required laboratory tests during screening
- Normal major organ function including heart, liver, and kidneys
- Hematologic parameters within specified limits (neutrophils, hemoglobin, platelets, bilirubin, liver enzymes, creatinine, coagulation times)
- No active hepatitis, AIDS, syphilis, or other infectious diseases
- Rheumatoid panel within specified limits (CRP, ASO, erythrocyte sedimentation rate)
- Thyroid function tests within specified normal ranges
- Adrenocorticotropic hormone within normal range
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Uncontrollable brain metastases
- Need for any antitumor treatment during the study including maintenance therapy, chemotherapy, or surgery
- Systemic corticosteroid or immunosuppressant use above specified doses within 14 days before first dose
- Anticancer immunotherapy or immunostimulatory drug use within 3 months before first dose
- Participation in another clinical trial with less than 4 weeks since last dose
- Severe cardiovascular diseases including recent myocardial infarction, cerebrovascular accidents, unstable arrhythmias, or unstable angina
- Uncontrolled myocardial ischemia or poorly controlled arrhythmias
- Hypertension not well controlled by medication
- Recent significant bleeding or bleeding tendency, tumors invading major blood vessels, or recent hemoptysis
- Arterial or venous thrombotic events within 3 months before screening
- Active tuberculosis
- Serious infections within 4 weeks before first dose or any active infection
- Preparation for or history of tissue/organ transplantation
- Uncontrolled epilepsy, central nervous system disorders, or neurological diseases causing cognitive impairment
- History of splenectomy
- Pregnancy or breastfeeding
- Severe allergy history or atopic constitution
- History of chronic alcohol or drug abuse within 6 months
- Deemed unsuitable for the study by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
2
The First Hospital of Nanchang
Nanchang, Jiangxi, China, 330006
Actively Recruiting
Research Team
Y
Yong Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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