Actively Recruiting
Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer
Led by Jinling Hospital, China · Updated on 2024-03-22
12
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
J
Jinling Hospital, China
Lead Sponsor
J
Jiangsu Synthgene Biotechnology Co.Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF).
- Subjects must be 18 years of age or older at time of informed consent.
- Subjects have radiographically resectable primary pancreatic tumors with features consistent with adenocarcinoma.
- Subjects have histologically confirmed resected ductal pancreatic adenocarcinoma with complete macroscopic resection (R0 or R1).
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG).
- Subjects have not had prior chemotherapy, radiation therapy, or immunotherapy for pancreatic ductal adenocarcinoma.
- Subjects have an estimated survival greater than 12 weeks.
You will not qualify if you...
- Prior neoadjuvant treatment, radiation therapy, anti-PD-1 antibody, or any other immune therapy for pancreatic ductal adenocarcinoma.
- Known hypersensitivity or allergy to SJ-neo006, camrelizumab, gemcitabine, or Abraxane.
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
- Known infection with hepatitis B or C, or history of HIV infection, or receiving immunosuppressive or myelosuppressive medications increasing neutropenic risk.
- Pregnancy, breastfeeding, or intending to become pregnant during the study or within 90 days after last study treatment.
- New York Heart Association Class III-IV heart failure, uncontrolled hypertension, significant cardiac conditions, cerebrovascular accident, transient ischemic attack, or seizure disorder.
- History of autoimmune disease such as lupus, rheumatoid arthritis, or inflammatory bowel disease.
- Any condition judged by investigators to increase risk or interfere with study outcomes.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wang Sizhen
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
X
Xinbo Wang, MD
CONTACT
S
Sizhen Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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