Individualized Neoantigen Therapy with Unusual Radiotherapy Enhancement (iNATURE)

Launched by THE UNIVERSITY OF HONG KONG-SHENZHEN HOSPITAL · Mar 10, 2024

Keywords

ClinConnect Summary

The iNATURE clinical trial is studying a new treatment approach for patients with advanced tumors. This trial combines a personalized vaccine made from the patient's own tumor markers (called neoantigens) with radiotherapy, a type of treatment that uses radiation to kill cancer cells. The researchers want to see how well this combination works in reducing tumor size, boosting the immune response, and extending patient survival.

To join the trial, participants should be adults over 18 years old with advanced or recurrent cancer that has not responded to standard treatments. They should have measurable tumors and an expected survival of at least three months. Participants will receive tailored treatment and will be closely monitored for their response and any side effects. It's important to know that women who can become pregnant must take precautions to avoid pregnancy during the trial. Overall, this study aims to explore a promising new way to treat difficult-to-manage cancers.

Gender

ALL

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