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Trial Title:
Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer
NCT ID:
NCT06326736
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Gemcitabine
Albumin-Bound Paclitaxel
Immune Checkpoint Inhibitors
Conditions: Keywords:
mRNA vaccine
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Tumors of patients with pancreatic cancer must be radiographically resectable, and
subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with
macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine
creation.
Arm group label:
Pancreatic Cancer
Other name:
Surgical resection
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
Camrelizumab will be administered 6 weeks post-tumor resection.
Arm group label:
Pancreatic Cancer
Other name:
PD-1 inhibitor
Intervention type:
Biological
Intervention name:
SJ-Neo006
Description:
SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks
post-tumor resection (+/- 2 weeks).
Arm group label:
Pancreatic Cancer
Other name:
Neoantigen mRNA Vaccines
Intervention type:
Drug
Intervention name:
Gemcitabine+Abraxane
Description:
Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.
Arm group label:
Pancreatic Cancer
Other name:
chemotherapy
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.
Detailed 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Wang Sizhen
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
wu qiong
Phone:
02580863234
Start date:
April 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Jinling Hospital, China
Agency class:
Other
Collaborator:
Agency:
Jiangsu Synthgene Biotechnology Co.Ltd.
Agency class:
Other
Source:
Jinling Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06326736