Actively Recruiting
Individualized Neoantigen Therapy with Unusual Radiotherapy Enhancement (iNATURE)
Led by The University of Hong Kong-Shenzhen Hospital · Updated on 2025-03-25
154
Participants Needed
2
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, the investigators provide an individualized tumor neoantigen peptide vaccine in combination with radiotherapy to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the individualized tumor neoantigen peptide vaccine in combination with radiotherapy
CONDITIONS
Official Title
Individualized Neoantigen Therapy with Unusual Radiotherapy Enhancement (iNATURE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age over 18 years old
- Diagnosed with advanced or recurrent malignancies confirmed by pathology and imaging
- Have failed systemic standard therapy or disease progression with no effective first-line therapy
- Have at least one measurable tumor lesion on imaging
- Expected survival time of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Access to sufficient tumor DNA or genomic data for neoantigen screening, or prepared neoantigen peptides from a certified company
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment and agree to use contraception during the study
- Willing and able to comply with study protocol and follow-up procedures
You will not qualify if you...
- No neoantigens detected in sequencing data
- History of bone marrow or stem cell transplantation
- Currently enrolled in other therapeutic clinical trials or Chinese medicine clinical trials
- Have active bacterial or fungal infections
- Have active HIV, hepatitis C, hepatitis B, herpes virus infections (except crusted lesions over 4 weeks), or respiratory viral infections (except cured for over 4 weeks)
- Have asthma, autoimmune disease, or immunodeficiency
- Receiving immunosuppressive drugs
- Severe coronary or cerebrovascular disease or other investigator concerns
- Clinical, psychological, or social factors affecting consent or study participation
- History of drug, peptide, or other immunotherapy allergies
- Lack capacity to make decisions for civil conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China, 518000
Actively Recruiting
2
University of Hong Kong-Shenzhen Hospital
Shenzhen, guangzhou, China
Enrolling by Invitation
Research Team
F
Feng-Ming (Spring) Kong
CONTACT
Y
Yan Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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