Actively Recruiting
Neoantigen-loaded DC Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC 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
In this study, the investigators provide a combined treatment of personalized tumor neoantigen-loaded dendritic cell (DC) vaccine, PD-1 Inhibitor, and radiotherapy to patients with advanced non-small cell lung cancer (NSCLC) progressed after second-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.
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
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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