在本研究中，研究者向晚期惡性實體瘤患者提供個體化腫瘤新抗原肽疫苗結合放射治療。研究者觀察治療後的腫瘤負荷狀態、免疫製劑所誘導的免疫反應，以及患者存活時間的延長，旨在評估個體化腫瘤新抗原肽疫苗結合的療效與安全性。
適應症：Advanced Tumors
收案條件
納入條件
- 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
排除條件
- 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
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。