Actively Recruiting
Personalized Tumor Neoantigen-loaded Dendritic Cell Vaccine Combined with 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
25 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) whose disease has progressed after first-line therapy. The study aims to assess the objective response rate, disease control rate, safety, progression-free survival, and overall survival of a treatment combining a personalized tumor neoantigen-loaded dendritic cell (DC) vaccine, PD-1 inhibitor, and radiotherapy. Participants will first undergo personalized radiotherapy. Following radiotherapy, they will receive PD-1 inhibitor injections every three weeks and a total of 10 subcutaneous injections of the personalized DC vaccine over 21 weeks. The vaccine treatment includes a primary phase of 6 doses spaced weekly then biweekly, followed by a boost phase of 4 doses spaced three weeks apart. The treatment plan is tailored individually with doctors overseeing each step. During the study, participants will have regular follow-up visits every 6 weeks until study completion, including blood collection, physical exams, performance status assessments, imaging scans (CT/MRI, X-ray), and laboratory tests. The research team will monitor treatment effects, side effects, and disease progression over an average of 32 weeks, with longer survival follow-up up to 66 months. The total study duration allows for careful evaluation of treatment response and safety.
CONDITIONS
Brief 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 requiring radiotherapy for metastatic lesions
- At least one measurable lesion
- Aged between 18 and 70 years, any gender
- Disease progression after standard first-line therapy with 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 negative pregnancy test and use effective contraception with no pregnancy plans for 6 months
- Ability to undergo all required laboratory screening tests
- Normal major organ function (heart, liver, kidney)
- Specific hematologic and biochemical parameters within defined normal limits
- No active hepatitis, AIDS, syphilis, or other infectious diseases
- Rheumatoid panel and thyroid function tests within specified ranges
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Uncontrollable brain metastases
- Need for any antitumor treatments during the study, including maintenance therapy, chemotherapy, or surgery
- Use of systemic corticosteroids or immunosuppressants within 14 days before first dose (except inhalational or topical corticosteroids without autoimmune disease)
- Treatment with anticancer immunotherapies or immunostimulatory drugs within 3 months before first dose
- Participation in other clinical trials with less than 4 weeks since last dose
- Severe cardiovascular diseases including recent myocardial infarction or cerebrovascular events, unstable arrhythmias or angina
- Uncontrolled myocardial ischemia or myocardial infarction, poorly controlled arrhythmias
- Hypertension not well controlled by medication (systolic ≥150 mmHg or diastolic ≥100 mmHg)
- Significant bleeding history or tumors invading major blood vessels with bleeding risk
- Recent arterial or venous thrombotic events within 3 months
- Active tuberculosis or serious infection within 4 weeks
- History of tissue or organ transplantation
- Uncontrolled epilepsy or neurological disorders causing cognitive impairment
- History of splenectomy
- Pregnant or breastfeeding women
- Severe allergy history or atopic constitution
- History of chronic alcohol or drug abuse within 6 months
- Deemed unsuitable by investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on individual treatment plan
Participants receive a personalized radiotherapy treatment course prior to other treatments.
Visit schedule determined by the participant's physician
Duration - 21 weeks
Participants receive combined treatment with PD-1 inhibitor injections every 3 weeks and 10 subcutaneous injections of personalized neoantigen-loaded DC vaccine over 21 weeks.
PD-1 inhibitor injections every 3 weeks; Vaccine injections 10 times with varying intervals
Duration - Until study completion (approximately 11 weeks after treatment)
After treatment, participants are followed with visits every 6 weeks including venous blood collection and various examinations.
Visits every 6 weeks
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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