Clinical Study of a Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Resectable Pancreatic Cancer
- Sponsor
- Zhejiang Provincial People's Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Relapse Free Survival(RFS)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
This research study is evaluating a new type of pancreatic cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for pancreatic cancer patients following surgical resection and adjuvant chemotherapy. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable pancreatic cancer, so as to provide a new personalized therapeutic strategy.
It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
Investigators
Liu Yang
MD
Zhejiang Provincial People's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Evidence of disease recurrence or metastasis following surgical resection at any time prior to the first vaccination administration.
- •Diagnosed as other malignant tumor;
- •No neoantigen was found in the sequencing data;
- •There have been bone marrow or stem cell transplants;
- •Received systemic glucocorticoids with immunosuppressants;
- •Received other polypeptide inoculation 4 weeks before treatment; Patients may not be vaccinated with other polypeptides 8 weeks after the last individualized tumor targeted polypeptides trentment;
- •With HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
- •Uncontrolled complications include, but are not limited to, active infection, symptomatic congestive heart failure, unstable angina pectoris, and arrhythmias;
- •Infected with herpes virus (except those with scabs of more than 4 weeks)；
- •Infected with respiratory virus (except those who have recovered for more than 4 weeks);
Outcomes
Primary Outcomes
Relapse Free Survival(RFS)
Time Frame: 4 years
Time from surgery to any recurrence
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time Frame: 1 years
Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Secondary Outcomes
- Overall Survival(OS)(4 years)