Overview
The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.
Description
The first purpose of this study is to evaluate the safety of treating pancreatic cancer with surgery to remove cancerour tissue.
Following with camrelizumab and a personalized Neoantigen mRNA Vaccines, and then with chemotherapy.
Eligibility
Inclusion Criteria:
- Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF).
- Subjects must be >/= 18 years of age at time of informed consent.
- Subjective with radiographically resectable primary pancreatic tumors with radiographic features consistent with adenocarcinoma will be evaluated for surgical resection.
- Subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation.
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG).
- Subjects must not have had prior chemotherapy, radiation therapy, or immunotherapy for Pancreatic ductal adenocarcinoma（PDAC）.
- Subjects with estimated survival > 12 weeks.
Exclusion Criteria:
- Prior neoadjuvant treatment, radiation therapy, anti-PD-1 antibody or any other immune therapy for pancreatic ductal adenocarcinoma.
- Known hypersensitivity or allergy to the active substance or to any of the excipients of SJ-neo006, Camrelizumab, Gemcitabine, Abraxane.
- Actie, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
- Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection or subjects receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications.
- Pregnancy, breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of study treatment.
- New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysthythmia, or electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
- History or autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease.
- Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.