Pancreatic Tumor Clinical Trial
Official title:
Clinical Trial to Evaluate Safety and Effect of Personalized Neoantigen Vaccine for Pancreatic Tumor Following Surgical Resection and Adjuvant Chemotherapy
This clinical trial is to evaluate the safety and impact on prognosis of personalized neoantigen peptide-based vaccines, which are based on next-generation sequencing and major histocompatibility complex affinity prediction algorithm, in patients with pancreatic ductal adenocarcinoma. The hypothesis of this study is that personalized neoantigen vaccines will be safe and can systemically elicit measurable neoantigen-specific immunologic responses in patients. Participants will receive complete macroscopic resection of primary tumor, standard adjuvant chemotherapy and subsequently personalized neoantigen vaccines.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 30, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Pathologic diagnosis of pancreatic ductal adenocarcinoma 2. Aged =20 and =75 3. Male or not pregnant women 4. Undergone radical resection (R0 status of resection margins [no cancer cells within 1 mm of all resection margins]) 5. No serious underlying disease, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. No chemotherapy or radiotherapy before resection surgery 7. No significant cardiac, lung, liver, kidney, and bone marrow insufficiency 8. No HIV or syphilis infection 9. Signing informed consent Exclusion Criteria: 1. Poor postoperative situation 2. Obvious organ dysfunction 3. Radiographically confirmed recurrence or metastasis within 180 days after the surgery 4. Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmias, Myocardial infarction in the past 6 months, and prolonged QT interval (> 450ms) 5. Previous malignant tumors other than pancreatic cancer 6. Cannot be follow up 7. Participating in other clinical trials 8. Without chemotherapy after resection surgery Exit criteria: 1. Missed within one month after surgery or not follow-up as required 2. Patient's own willingness to withdraw 3. Concurrent disease or severe adverse events 4. Protocol violations 5. Administrative reasons |
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Anda Biopharmaceutical Development (Shenzhen) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Levels of interferon-? responses in peripheral blood mononuclear cells | Ex vivo Enzyme-linked Immunospot assay will be performed to detect the levels of interferon-? responses of the neoantigen peptides in the stimulation of peripheral blood mononuclear cells. Data will be presented as the ratio of the adjusted spot-forming count of peptide stimulation to the corresponding non-stimulated negative control. | From the date of first dose of vaccination through 264 days after the first dose of vaccination. | |
Other | Percentages of immune cell populations in peripheral blood during the vaccination | The percentages of immune cells including natural killer (NK) cells, T cells, B cells, macrophages, monocytes, dendritic cells and granulocytes as well as their subtypes will be detected in the peripheral blood of patients during the vaccination. The percentages of specific T-cell or B-cell clonotypes will also be detected during the vaccination. Ten-color flow cytometry and single-cell transcriptome sequencing will be performed to evaluate the percentage of the immune cell populations. Single-cell T/B-cell repertoire sequencings will be performed to profile the expansion of T-cell or B-cell clonotypes. | From the date of first dose of vaccination through 264 days after the first dose of vaccination. | |
Primary | Incidence and grades of adverse events as assessed by CTCAE v5.0 | Safety will be assessed by the rate of grade 3 or worse adverse events (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0). | From the first dose of vaccination through 2 years after the surgery | |
Secondary | Recurrence-free survival | The time between resection surgery and the tumor recurrence (radiological assessment of disease status according to RECIST1.1 criteria). | From the date of resection surgery until the date of the first confirmed tumor recurrence or date of death from any cause or date of study completion, whichever came first, assessed up to 6 years. | |
Secondary | Overall survival | The time between resection surgery and the death (any cause). | From the date of resection surgery until the date of death from any cause or date of study completion, whichever came first, assessed up to 6 years. | |
Secondary | Serum CA19-9 or CA72-4 levels | The rate of patients without the abnormal elevation of the serum CA19-9 (Cancer Antigen 19-9) or CA72-4 (Cancer Antigen 72-4) levels will be assessed during the vaccination and post-treatment follow-up. | From the date of resection surgery until the date of last documented examination of CA19-9 and CA72-4 or date of study completion, whichever came first, assessed up to 6 years. |
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