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2018-07-12
2023-11-30
2023-12-30
30
NCT03558945
Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.
Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.
INTERVENTIONAL
Clinical Trial on Personalized Neoantigen Vaccine for Pancreatic Tumor
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.
This is a single-center, open-label Phase Ib clinical trial. In this trial, adult subjects with pancreatic ductal adenocarcinoma who have completed resection of the primary tumor and who have not undergone preoperative chemotherapy will be enrolled in the study. Eligible enrolled patients all will undergo tumor resection and all receive adjuvant chemotherapy prior to preparation of the personalized neoantigen vaccine. After the chemotherapy finish, subsequently patients will receive a priming immunization with five doses of the personalized neoantigen vaccine over one month and a boosting immunization with two doses three months later. This clinical trial will examine the safety and effect of the personalized neoantigen vaccine when given at several different time points and will examine the participant's peripheral blood cells for signs that the vaccine induces immunologic responses. 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-05-24 | N/A | 2023-04-21 |
2018-06-05 | N/A | 2023-04-24 |
2018-06-15 | N/A | 2023-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Personalized neoantigen vaccine Patients will receive radical resection surgery and at least one circle of post-operative chemotherapy. After chemotherapy, personalized neoantigen vaccines will be administered subcutaneously. | BIOLOGICAL: Personalized neoantigen vaccine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Shiwei Guo, Doctor Phone Number: +8618621500666 Email: gestwa@163.com |
Study Contact Backup Name: Suizhi Gao, Master Phone Number: +8613167137990 Email: gaosuizhi@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
