advanced pancreatic cancer
Conditions
Interventions
Individualized tumor polypeptide vaccine combined with chemotherapy group:Personalized tumor polypeptide vaccine + chemotherapy
Sponsors
Taizhou Hospital of Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the study; 2. Age: 18-80 years old, male or female; 3. Patients with advanced or recurrent pancreatic cancer diagnosed by pathology and imaging, who have received systematic standard treatment before admission and have failed or the disease has progressed, and currently have no effective first-line treatment (for effective treatment, refer to the latest version of diagnosis and treatment guidelines issued by the Chinese Society of Clinical Oncology); 4. There is at least one radiologically measurable lesion; 5. Patients with expected survival =3 months; 6. Patients with ECOG (Eastern Cooperative Oncology Group, Eastern Cooperative Oncology Group) score 0-2; 7. Have access to sufficient tumor DNA (circulating tumor DNA or tissue samples) for analysis, or have genomic/exon/transcription data of tumor tissue and normal tissue, and the data meet the analysis requirements, tumor neoantigen screening is qualified, or have prepared neoantigen polypeptides from a certified company (GMP); 8. Pregnant women, breastfeeding women, women of childbearing age who had a negative pregnancy test within 7 days prior to enrollment, had no short-term family planning, and were willing to take protective measures (contraception or other birth control methods) before and during the clinical trial; 9. Good compliance, able to follow the study protocol and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. No neoantigens were found in sequencing data; 2. Patients with a history of bone marrow or stem cell transplantation; 3. Participating in other therapeutic clinical trials; 4. Clinical trial of Chinese medicine 4. Clinically found active bacterial or fungal infections >= NCI-CTC (the National Cancer Institute's General Standard for drug Toxicity, Common drug toxicity standards developed by the National Cancer Institute) CTCAE5.0; 5. HIV (human immunodeficiency virus, human immunodeficiency virus), HCV (hepatitis C virus, hepatitis C virus), HBV (Hepatitis B virus, Patients with hepatitis B virus, severe asthma, autoimmune disease, immune deficiency, or treatment with immunosuppressive drugs; 6. Herpes virus infection (except for more than 4 weeks of scab); 7. People infected with respiratory viruses (except those cured for more than 4 weeks); 8. Severe coronary artery or cerebrovascular disease, or other disease that the investigator considers to be excluded;9. Clinical, psychological or social factors affecting informed consent or the conduct of the study; 10. People with a history of allergy to drugs or peptides, or to other potential immunotherapies; 11. Patients without civil capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Immunogenicity;Overall survival;objective response rate; | — |
Countries
China
Contacts
Public ContactFabiao Zhang
Department of Hepatobiliary Surgery, East Hospital, Linhai Taizhou Hospital, Taizhou City, Zhejiang
Outcome results
None listed