advanced tumors
Conditions
Interventions
Control group: placebo + conventional treatment (including radiotherapy) group:conventional treatment (including radiotherapy)
Intervention group: individualized tumor polypeptide vaccine + conventional treatment (including radiotherapy) group:Personalized tumor polypeptide vaccine
Sponsors
The University of Hong Kong-Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria simultaneously to be enrolled in this study. 1.voluntarily join the study. 2.Age: 18-80 years old, male or female. 3.subjects 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 measurable imaging lesion. 5.patients with an expected survival of = 3 months. 6.patients 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. pregnant women, lactating women, negative pregnancy tests within 7 days prior to enrollment, and Women of childbearing age who 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. Good compliance and able to follow the study protocol and follow-up procedures.
Exclusion criteria
Exclusion criteria: Patients with any of the following could not be enrolled in this study. 1.no new antigens were found in the sequencing data. 2.those with a history of bone marrow or stem cell transplantation . 3.being involved in other therapeutic clinical trials; clinical trials of Chinese medicine 4.clinically active bacterial or fungal infections found >= NCI-CTC (Common drug toxicity standards developed by the National Cancer Institute) CTCAE5.0. 5.infected with HIV (human immunodeficiency virus, human immunodeficiency virus), HCV (hepatitis C virus, hepatitis C virus), HBV (hepatitis B virus, hepatitis B virus), severe asthma, autoimmune disease, immunodeficiency, or treatment with immunosuppressive drugs Patients. 6.persons infected with the herpes virus (except for crusting for more than 4 weeks). 7.persons with respiratory viral infections (except for those who have been cured for more than 4 weeks). 8.severe coronary or cerebrovascular disease, or other conditions that the investigator believes should be excluded. 9. clinical, psychological or social factors affecting informed consent or study implementation. 10. A history of drug or peptide allergy, or allergy to other potential immunotherapies. 11.persons without capacity for civil conduct.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events in all treated subjects;Overall survival;Objective remission rate;Local radiotherapy in the field response;Distant response rate; | — |
Countries
China
Contacts
Public ContactFengming Kong
The University of Hong Kong-Shenzhen Hospital, Shenzhen, Guangdong, 518053, China
Outcome results
None listed