Individualized Neoantigen Therapy with Unusual Radiotherapy Enhancement (iNATURE)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Advanced Tumors

In brief

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

Key facts

Study ID: NCT06314087
Run by: The University of Hong Kong-Shenzhen Hospital
People needed: 154
Starts: 2024-01-31
Expected to finish: 2026-08-31
Last updated by the study team: 2025-03-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

male or female
age>18 years old
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)
have at least one imaging measurable lesion
with an expected survival of ≥ 3 months
with an ECOG (Eastern Cooperative Oncology Group) score of 0-2
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)
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
compliant patients who is and able to follow the study protocol and the follow-up procedures

You may not qualify if…

No neoantigens detected in the sequencing data.
with a history of bone marrow or stem cell transplantation
enrolled in other therapeutic clinical trials; clinical trials of Chinese medicine
with active bacterial or fungal infections
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)
with asthma, autoimmune disease, immunodeficiency
under treatment with immunosuppressive drugs
with severe coronary or cerebrovascular disease, or other conditions that concerns the investigator for enrollment
have clinical, psychological or social factors affecting informed consent or study implementation
have a history of drug or peptide allergy, or allergy to other potential immunotherapies
no decision making capacity for civil conduct

Where it is running

University of Hong Kong-Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)
University of Hong Kong-Shenzhen Hospital — Shenzhen, guangzhou, China

Full record on ClinicalTrials.gov

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