Pancreatic CancerEarly Phase 1NCT06326736
Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer
A Early Phase 1 study testing Surgery, Camrelizumab and SJ-Neo006 in people with Pancreatic Cancer, run by Jinling Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Surgery, Camrelizumab and SJ-Neo006
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Apr 2024to Dec 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wang Sizhen
Nanjing, Jiangsu
wu qiong, 02580863234
About this study
Official title: An Exploratory Clinical Study of Safety and Efficacy of Neoantigen mRNA Vaccines in the Treatment of Patients With Resectable Pancreatic Cancer
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Surgery, Camrelizumab, SJ-Neo006, Gemcitabine+Abraxane
- Keywords
- mRNA vaccine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Surgical resection
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.
CamrelizumabDrug
Also called PD-1 inhibitor
Camrelizumab will be administered 6 weeks post-tumor resection.
SJ-Neo006Biological
Also called Neoantigen mRNA Vaccines
SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks).
Gemcitabine+AbraxaneDrug
Also called chemotherapy
Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer | Experimental | Resectable primary pancreatic tumor Receives: Procedure: Surgery; Drug: Camrelizumab; Biological: SJ-Neo006; Drug: Gemcitabine+Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAEs)
To observe and evaluate the safety of Neoantigen mRNA vaccine combined with Camrelizumab, for the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: 2 years
Secondary outcomes (1)
Disease control rate (DCR)
The efficacy of Neoantigen mRNA vaccine combined with Camrelizumab by tumor lesion recurrence cycle at different time.
Measured: 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Synthgene Biotechnology Co.Ltd.
- Responsible party
- Principal investigator, Sizhen Wang, Jinling Hospital, China
- Investigators
- Xinbo Wang, MD, Study director, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326736
- Sponsor's protocol ID
- 2024NZKY-014-02
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No