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NCT06326736RecruitingEarly phase 1

Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer

An Exploratory Clinical Study of Safety and Efficacy of Neoantigen mRNA Vaccines in the Treatment of Patients With Resectable Pancreatic Cancer

Source: ClinicalTrials.gov · Last updated 22 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
12 (estimated)
First submitted
11 Mar 2024
Start date
Apr 2024
Primary completion date
Dec 2025
Lead sponsor
Jinling Hospital, China
NCT number
NCT06326736

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 12
  • From Apr 2024 to the primary completion date, Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior neoadjuvant treatment, radiation therapy, anti-PD-1 antibody or any other immune therapy for pancreatic ductal adenocarcinoma.
  • 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.

Other illness

  • 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.
  • 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.

Other

  • Pregnancy, breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of study treatment.
  • Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Wang Sizhen
Coordinator of this site? Confirm its status
NanjingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.