NCT06314087 Individualized Neoantigen Therapy with Unusual Radiotherapy Enhancement (iNATURE)
| NCT ID | NCT06314087 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Hong Kong-Shenzhen Hospital |
| Condition | Advanced Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2026-08-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 154 participants in total. It began in 2024-01-31 with a primary completion date of 2026-08-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Clinical Cancer Center Hong Kong University Shenzhen Hospital
PRINCIPAL INVESTIGATOR
Municipal hospitals
Frequently Asked Questions
Who can join the NCT06314087 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Advanced Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06314087 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06314087 currently recruiting?
Yes, NCT06314087 is actively recruiting participants. Contact the research team at Kong001@hku.hk for enrollment information.
Where is the NCT06314087 trial being conducted?
This trial is being conducted at Shenzhen, China, Shenzhen, China.
Who is sponsoring the NCT06314087 clinical trial?
NCT06314087 is sponsored by The University of Hong Kong-Shenzhen Hospital. The principal investigator is Clinical Cancer Center Hong Kong University Shenzhen Hospital at Municipal hospitals. The trial plans to enroll 154 participants.