Actively Recruiting
Neoantigen-loaded DC Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After First-line Treatment
Led by The First Affiliated Hospital of Nanchang University · Updated on 2024-12-30
10
Participants Needed
2
Research Sites
130 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 first-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 First-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 years, any gender
- Disease progression after standard first-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 patients of childbearing age must have a negative pregnancy test and use effective contraception with no plans for pregnancy within 6 months
- Able to complete all required screening laboratory tests
- Normal major organ function including heart, liver, and kidneys
- Hematologic parameters meeting specific thresholds for neutrophils, hemoglobin, platelets, bilirubin, liver enzymes, creatinine, coagulation times
- No active hepatitis, AIDS, syphilis, or other infectious diseases
- Rheumatoid panel values within specified limits
- Thyroid function tests within specified normal ranges
- Adrenocorticotropic hormone levels within 1.1-17.6 pmol/L
- 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 within 14 days before first dose (inhalational or topical corticosteroids allowed without active autoimmune disease)
- Anticancer immunotherapy or immunostimulatory drug use within 3 months before first dose
- Participation in other clinical trials within 4 weeks or 5 half-lives of study drug
- Severe cardiovascular diseases including recent myocardial infarction, cerebrovascular events, unstable arrhythmias, or unstable angina
- Uncontrolled hypertension despite medication
- Significant bleeding or bleeding tendency within 3 months before first dose
- Arterial or venous thrombotic events within 3 months before screening
- Active tuberculosis or serious infection within 4 weeks before first dose
- Tissue or organ transplant history or preparation
- Uncontrolled epilepsy, central nervous system or neurological disorders causing cognitive impairment
- History of splenectomy
- Pregnant or breastfeeding women
- Severe allergy history or atopic constitution
- Chronic alcohol or drug abuse within 6 months before enrollment
- Deemed unsuitable for the study by the 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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