在本研究中，研究者向晚期恶性实体瘤患者提供个体化肿瘤新抗原肽疫苗结合放射治疗。研究者观察治疗后的肿瘤负荷状态、免疫制剂所诱导的免疫反应，以及患者存活时间的延长，旨在评估个体化肿瘤新抗原肽疫苗结合的疗效与安全性。
适应症：Advanced Tumors
入组条件
纳入标准
- 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
排除标准
- 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
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。