Actively Recruiting
Neoantigen-based Peptide 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-based peptide 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-based Peptide 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 requiring radiotherapy for metastatic lesions
- At least one measurable lesion
- Aged between 18 and 70 years, any gender
- Disease progressed after standard second-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 a negative pregnancy test and agree to effective contraception with no pregnancy plans for 6 months
- Ability to undergo all required screening laboratory tests
- Normal major organ function including heart, liver, and kidney
- Hematologic parameters within specified limits (neutrophils, hemoglobin, platelets, bilirubin, liver enzymes, creatinine, blood urea nitrogen, coagulation times)
- No active hepatitis, AIDS, syphilis, or other infectious diseases
- Rheumatoid panel results within defined ranges
- Thyroid function tests within 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 other antitumor treatment during the study including maintenance therapy, chemotherapy, or surgery
- Systemic corticosteroid or immunosuppressant use above 10 mg/day prednisone equivalent within 14 days before first dose (inhaled/topical corticosteroids allowed if no active autoimmune diseases)
- Anticancer immunotherapy or immunostimulatory drug use within 3 months before first dose
- Participation in other clinical trials with less than 4 weeks since last dose
- Severe cardiovascular diseases (NYHA Class II or higher, recent myocardial infarction, cerebrovascular events within 3 months, unstable arrhythmias or angina)
- Uncontrolled myocardial ischemia or infarction, poorly controlled arrhythmias
- Uncontrolled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg)
- Significant bleeding symptoms 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 before first dose
- Tissue or organ transplant history or preparation
- Uncontrolled epilepsy, CNS disorders, or neurological diseases 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 any reason
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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