NCT06326736 Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer
| NCT ID | NCT06326736 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Jinling Hospital, China |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-04 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-04 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Xinbo Wang, MD
STUDY DIRECTOR
Jinling Hospital, China
Frequently Asked Questions
Who can join the NCT06326736 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06326736 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06326736 currently recruiting?
Yes, NCT06326736 is actively recruiting participants. Contact the research team at wxinbo2008@163.com for enrollment information.
Where is the NCT06326736 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06326736 clinical trial?
NCT06326736 is sponsored by Jinling Hospital, China. The principal investigator is Xinbo Wang, MD at Jinling Hospital, China. The trial plans to enroll 12 participants.
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