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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

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