personalized tumor neoantigen mrna therapy for advanced pancreatic cancer.

Conditions: Pancreatic Cancer Metastatic; Pancreatic Cancer Non-resectable

Summary: this study is a single-arm phase i/ii clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mrna therapy (ineo-vac-r01) in combination with pd-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: (1) subjects who meet all the following entry criteria enter the pre-screening phase of the study: 1. voluntary signing of the informed consent form; 2. age: 18 and 75 years old, male or female; 3. evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 nccn guidelines; 4. no systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy. 5. an eastern cooperative oncology group (ecog) physical fitness status score of 0 or 1; 6. according to the efficacy evaluation criteria for solid tumors (recist 1.1); 7. can obtain sufficient fresh tumor tissue samples for exome and transcriptome sequencing analysis; 8. main organ function of heart, liver and kidney is normal: 9. ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age included premenopause and women within 2 years after menopause; 10. ability to follow the study protocol and follow-up procedures. (2) subjects who meet all the following enrollment criteria enter the formal screening stage of the study and enter the study medication process: 1. voluntary signing of the informed consent form; 2. age: 18 and 75 years old, male or female; 3. pancreatic ductal adenocarcinoma (pdac) diagnosed by pathology (histology or cytology); 4. no systemic treatment or gemcitabine-based first-line chemotherapy. 5. an eastern cooperative oncology group (ecog) physical fitness status score of 0 or 1; 6. main organ function of heart, liver and kidney is normal: 7. ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age include premenopause and women within 2 years after menopause; 8. ability to follow the study protocol and follow-up procedures. exclusion criteria: subjects will be excluded from this study if they meet any of the following criteria: 1. pancreatic cancer has central nervous system metastasis or meningeal metastasis; 2. at the same time with other malignant tumors, but cured basal cell cancer, thyroid cancer, cervical dysplasia, etc., have been in the disease for more than 5 years or do not considered to be easy to relapse except; 3. history of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation; 4. patients with immunosuppressants, that is, those who require regular use of immunosuppressants 4 weeks before the screening period and the clinical study, including but not limited to the following conditions: severe asthma, autoimmune diseases or immune deficiency, treated with immunosuppressive drugs, and known history of primary immunodeficiency; except type 1 diabetes, autoimmune-related hypothyroidism requiring hormone therapy, vitiligo and psoriasis that do not require systemic therapy; 5. active bacterial or fungal infection identified by clinical diagnosis; a history of active tb or tuberculosis; 6. patients with positive human immunodeficiency virus (hiv) antibody, positive treponema pallidum for syphilis (tp) antibody, active hepatitis c (positive hepatitis c virus (hcv) antibody and positive hcv rna result), active hepatitis b; 7. herpesvirus infection (except those who scab for more than 4 weeks); respiratory virus infection (except those who have recovered for more than 4 weeks); 8. uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases considered unacceptable by the investigator; 9. previous history of drug abuse, clinical or psychological or social factors affecting informed consent or study implementation; a history of mental illness; 10. patients with a history of food, drug or vaccine allergy or other potential immunotherapy allergies as considered by the investigator. 11. women born during pregnancy or lactation; 12. the investigator is not fit for enrollment or may not complete the trial for other reasons.