Clinical Trial on Personalized Neoantigen Vaccine for Pancreatic Tumor
Study Details
Study Description
Brief Summary
This clinical trial is to evaluate the safety and effect of personalized neoantigen vaccines, which are based on next-generation sequencing and MHC affinity prediction algorithm. The hypothesis of this study is that personalized neoantigen vaccines will be safe and capable of generating measurable neoantigen-specific CD4 and CD8 T cell responses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This research study is a Phase I clinical trial, which tests the safety and effect of personalized neoantigen vaccines for pancreatic tumors. It is known that pancreatic tumors have various mutations (changes in genetic material) that are specific to an individual patient and tumors. 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 pancreatic tumors to come back after radical surgery. The study will examine the safety and effect 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. Finally we will establish the typical flow to assess efficiency and safety of vaccines according to the different reactivity of patients, as a result, to explore the most suitable practical approaches for applying personalized pancreatic tumor vaccines.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Personalized neoantigen vaccine Patients will receive radical surgery and at least one circle of post-operative chemotherapy. Personalized neoantigen vaccines will be injected on day 1 of weeks 1, 3, 5, 7, 9, short interval or 1-2 months after the end of their post-operative chemotherapy, and two boosts will be on day 1 of weeks 12, 20. Vaccines will be given in a total volume of up to 1.0ml/shot consisting of 0.3mg peptide+0.5mg ployICLC injected subcutaneously into two to four separate sites of the subject's thighs. Patients will be called 2 times by study staff in the 6 months after last dose of vaccine and asked about any side effects experienced since the end-of-study visit. |
Biological: Personalized neoantigen vaccine
Personalized neoantigen vaccines will be injected on day 1 of weeks 1, 3, 5, 7, 9, short interval or 1-2 months after the end of their post-operative chemotherapy, and two boosts will be on day 1 of weeks 12, 20.
Vaccines will be given in a total volume of up to 1.0ml/shot consisting of 0.3mg peptide+0.5mg ployICLC injected subcutaneously into two to four separate sites of the subject's thighs.
|
| No Intervention: Conventional treatment Patients will receive radical surgery and conventional post-operative chemotherapy. |
Outcome Measures
Primary Outcome Measures
- Overall time [From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months]
The time between operation and the death of patients
Secondary Outcome Measures
- Disease free time [From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months]
The time between operation and the relapse or metastasis of tumors
- Immunogenicity of the personalized neoantigen vaccine [Through week 77]
Immunogenicity of the personalized neoantigen vaccine will be measured by the frequency of antigen -specific T cells using ELISPOT analysis.
- Incidence of Treatment-Emergent Adverse Events [Through week 20]
Safety of personalized neoantigen vaccine will be measured by the number of subjects experiencing each type of adverse event. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or non-pregnant female pancreatic cancer patients aged from 20 to 75 years;
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Have accepted surgery of radical resection;
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With no severe basic diseases;
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Have never suffered radiotherapy or chemotherapy before;
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Pathologically confirmed as pancreatic cancer;
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With no apparent cardiopulmonary renal dysfunction;
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With no affection of HIV, syphilis virus or other infectious diseases;
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Have signed informed consent.
Exclusion Criteria:
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Terrible general conditions to accept surgery or post-operation chemotherapy;
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With cancer metastasis;
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Have severe basic diseases;
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Have malignant tumors in other organs in nearly five years;
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Could not accept follow up or have participated other clinical trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Changhai Hospital | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Changhai Hospital
Investigators
- Principal Investigator: Gang Jin, Doctor, Changhai Hospital, Shanghai, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ChanghaiH-PP03