Actively Recruiting
Study of Personalized Tumor Neoantigen-loaded DC Vaccine Combined with PD-1 Inhibitor and Radiotherapy for Advanced Non-Small Cell Lung Cancer After First-Line Treatment Progression
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
Researchers are evaluating a combined treatment approach for patients with advanced non-small cell lung cancer (NSCLC) that has progressed after first-line treatment. This approach includes a personalized tumor neoantigen-loaded dendritic cell (DC) vaccine, a PD-1 inhibitor, and radiotherapy. The study aims to observe objective response rate (ORR), disease control rate (DCR), adverse events, progression-free survival (PFS), and overall survival (OS) to assess the effectiveness and safety of this combined treatment. Participants will first receive personalized radiotherapy tailored to their metastatic lesions. After completing radiotherapy, PD-1 inhibitor injections will be administered intravenously every three weeks. Alongside, the personalized DC vaccine treatment will be given in two phases: the primary phase consists of six treatments with specific spacing (the first three treatments one week apart and the next three two weeks apart), and the boost phase includes four treatments spaced three weeks apart. Vaccine injections will be given subcutaneously on the fourth day of each treatment week. The entire vaccine treatment period lasts 21 weeks. During the study, participants will undergo regular follow-up visits every six weeks until the study ends, which averages about 32 weeks. At each visit, doctors will perform blood collections, physical examinations, performance status assessments, imaging scans (CT/MRI and X-rays), laboratory tests, and other necessary evaluations. Researchers will monitor treatment responses, disease control, and safety throughout the study to gather comprehensive data on the combined treatment's impact.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here