Actively Recruiting
Personalized Tumor Neoantigen-loaded DC Vaccine Combined with 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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment for patients with advanced non-small cell lung cancer (NSCLC) that has worsened after second-line therapy. The study aims to assess the effectiveness and safety of using a personalized tumor neoantigen-loaded dendritic cell (DC) vaccine together with a PD-1 inhibitor and radiotherapy. This phase 2 study involves 10 patients and follows strict ethical guidelines. The treatment includes a personalized course of radiotherapy followed by PD-1 inhibitor infusions every three weeks. Alongside this, patients receive 10 subcutaneous injections of the personalized neoantigen-loaded DC vaccine over 21 weeks. The vaccine administration is divided into a primary phase with six treatments and a boost phase with four treatments, scheduled at specific intervals. Radiotherapy details and dosage are tailored by the patient's physician. Participants will undergo regular follow-up visits every six weeks after treatment until the study ends. At each visit, they will have blood samples taken, physical exams, performance status assessments, imaging scans such as CT or MRI, X-rays, and laboratory tests. Researchers will monitor outcomes including objective response rate, disease control rate, safety measures, progression-free survival, and overall survival throughout an average study duration of 32 weeks or longer as applicable.
CONDITIONS
Brief Title
Neoantigen-loaded DC 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 who require radiotherapy for metastatic lesions
- At least one measurable lesion
- Aged 18 to 70 years, any gender
- Disease progression 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 use effective contraception with no plans for pregnancy within 6 months
- Able to complete all required laboratory tests during screening
- Normal major organ function including heart, liver, and kidney
- Specific hematologic and biochemical parameters within defined limits as outlined in protocol
- No active hepatitis, AIDS, syphilis, or other infectious diseases
- Rheumatoid panel and thyroid function tests within specified normal ranges
- Ability to understand and voluntarily sign informed consent form
You will not qualify if you...
- Uncontrollable brain metastases
- Need for other antitumor treatments during the study including chemotherapy, maintenance therapy, or surgery
- Use of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days before first dose
- Previous anticancer immunotherapies or immunostimulatory drugs within 3 months before first dose
- Participation in other clinical trials within 4 weeks or 5 half-lives of the study drug
- Severe cardiovascular diseases within 3 months prior or unstable heart conditions
- Uncontrolled hypertension despite medication
- Significant bleeding history or tumors invading major blood vessels with risk of bleeding
- Recent arterial or venous thrombotic events within 3 months
- Active tuberculosis or serious infections within 4 weeks before first dose
- History of tissue/organ transplantation
- Uncontrolled epilepsy, central nervous system 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
- Investigator deems participant unsuitable for the study
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 - Variable duration as determined by physician
Participants receive a personalized radiotherapy treatment course determined by their physician before starting other treatments.
Number and frequency of visits depend on personalized radiotherapy plan
Duration - 21 weeks
Participants receive PD-1 inhibitor injections every 3 weeks and 10 subcutaneous injections of the personalized neoantigen-loaded DC vaccine over a 21-week period.
PD-1 inhibitor injections every 3 weeks and vaccine injections on a schedule with initial 6 doses (first 3 weekly, next 3 biweekly) followed by 4 doses every 3 weeks
Duration - Up to study completion (approximately 11 weeks after treatment)
Participants are followed every 6 weeks after treatment to monitor health through blood collection, physical exams, imaging, and other necessary assessments.
Visits every 6 weeks until study completion
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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