Actively Recruiting
Neoantigen-based Peptide 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-based peptide 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-based Peptide 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 confirmed advanced NSCLC needing radiotherapy for metastatic lesions
- At least one measurable lesion
- Aged between 18 and 70 years, any gender
- Disease progressed after standard first-line therapy and more than 2 weeks since last antitumor treatment
- Expected survival of 3 months or more
- ECOG performance status score of 0 or 1
- Female patients of childbearing age must have a negative pregnancy test and use effective contraception for 6 months
- Able to complete all required lab tests during screening
- Normal major organ function including heart, liver, and kidney
- Blood counts and liver/kidney function within specified limits
- No active hepatitis, AIDS, syphilis, or other infections
- Rheumatoid markers within normal ranges
- Thyroid function tests within normal ranges
- Adrenocorticotropic hormone level within normal range
- Able 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 chemotherapy, surgery, or maintenance therapy
- Use of systemic corticosteroids (>10 mg/day prednisone or equivalent) or immunosuppressants within 14 days before first dose
- 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 such as recent myocardial infarction or unstable arrhythmias
- Uncontrolled myocardial ischemia or arrhythmias
- Poorly controlled hypertension
- Significant bleeding symptoms or tumors invading major blood vessels
- Recent arterial or venous thrombotic events within 3 months before screening
- Active tuberculosis or serious infections within 4 weeks before first dose
- History of tissue or organ transplantation
- Uncontrolled epilepsy or neurological disorders causing cognitive impairment
- History of splenectomy
- Pregnant or breastfeeding women
- Severe allergies or atopic conditions
- History of chronic alcohol or drug abuse within 6 months
- Any condition deemed unsuitable 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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