Personalized neoantigen vaccine combined with radiotherapy for advanced tumors
Individualized Tumor Neoantigen Peptide Vaccine in Combination with Unusual Immune Stimulating Radiotherapy in Refractory Solid Tumors (iNATURE) - a Phase II Randomized and Crossover Study
This study is testing a personalized vaccine made from a patient's own tumor cells combined with radiotherapy to see if it can help people with advanced tumors that haven't responded to standard treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Hong Kong-Shenzhen Hospital Academic / other |
| Locations | 2 sites (Shenzhen, Guangdong and 1 other locations) |
| Trial ID | NCT06314087 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of an individualized tumor neoantigen peptide vaccine in combination with radiotherapy for patients with advanced malignant solid tumors that have not responded to standard treatments. Patients will undergo tumor tissue collection and genomic analysis to identify specific neoantigens, which will then be used to create a personalized vaccine. The study will monitor tumor burden, immune response, and patient survival following treatment. The approach involves a multi-step process including sequencing, neoantigen prediction, and validation by multiple teams to ensure accuracy.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with advanced or recurrent malignancies that have failed standard therapies and have measurable lesions.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients with advanced tumors who have limited therapeutic options.
How similar studies have performed: While the use of neoantigen vaccines is a growing area of interest, this specific combination with radiotherapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. male or female 2. age\>18 years old 3. with advanced or recurrent malignancies diagnosed by pathology and imaging, who have failed systemic standard therapy or disease progression prior to enrollment and have no effective first-line therapy (for effective therapy, refer to the latest version of the treatment guidelines published by the Chinese Society of Clinical Oncology) 4. have at least one imaging measurable lesion 5. with an expected survival of ≥ 3 months 6. with an ECOG (Eastern Cooperative Oncology Group) score of 0-2 7. have access to sufficient tumor DNA (circulating tumor DNA or tissue samples) for analysis, or have genomic/exonic/transcriptional data from tumor and normal tissues and the data meet the analysis requirements, qualified for tumor neoantigen screening, or have prepared neoantigen peptides from a certified company (GMP) 8. women of childbearing age should have negative pregnancy tests within 7 days prior to enrollment, and have no short-term plans to have children and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial 9. compliant patients who is and able to follow the study protocol and the follow-up procedures Exclusion Criteria: 1. No neoantigens detected in the sequencing data. 2. with a history of bone marrow or stem cell transplantation 3. enrolled in other therapeutic clinical trials; clinical trials of Chinese medicine 4. with active bacterial or fungal infections 5. with active HIV (human immunodeficiency virus, human immunodeficiency virus), HCV (hepatitis C virus), HBV (hepatitis B virus), or the herpes virus (except for crusting for more than 4 weeks), or with respiratory viral infections (except for those who have been cured for more than 4 weeks) 6. with asthma, autoimmune disease, immunodeficiency 7. under treatment with immunosuppressive drugs 8. with severe coronary or cerebrovascular disease, or other conditions that concerns the investigator for enrollment 9. have clinical, psychological or social factors affecting informed consent or study implementation 10. have a history of drug or peptide allergy, or allergy to other potential immunotherapies 11. no decision making capacity for civil conduct
Where this trial is running
Shenzhen, Guangdong and 1 other locations
- University of Hong Kong-Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
- University of Hong Kong-Shenzhen Hospital — Shenzhen, guangzhou, China (Enrolling_by_invitation)
Study contacts
- Principal investigator: Clinical Cancer Center Hong Kong University Shenzhen Hospital — Municipal hospitals
- Study coordinator: Feng-Ming (Spring) Kong
- Email: Kong001@hku.hk
- Phone: 18807550703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.