Clinical Trial on Personalized Neoantigen Vaccine for Pancreatic Tumor
Clinical Trial to Evaluate Safety and Effect of Personalized Neoantigen Vaccine for Pancreatic Tumor Following Surgical Resection and Adjuvant Chemotherapy
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2018
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedStudy Start
First participant enrolled
July 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedApril 24, 2023
March 1, 2023
5.4 years
May 24, 2018
April 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Recurrence-free survival
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
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
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.
Other Outcomes (2)
Levels of interferon-γ responses in peripheral blood mononuclear cells
From the date of first dose of vaccination through 264 days after the first dose of vaccination.
Percentages of immune cell populations in peripheral blood during the vaccination
From the date of first dose of vaccination through 264 days after the first dose of vaccination.
Study Arms (1)
Personalized neoantigen vaccine
EXPERIMENTALPatients will receive radical resection surgery and at least one circle of post-operative chemotherapy. After chemotherapy, personalized neoantigen vaccines will be administered subcutaneously.
Interventions
Patients will have complete resection of primary tumor without preoperative chemotherapy. Patients will receive postoperative chemotherapy and subsequently personalized vaccines on days 1, 4, 8, 15, 22 (priming phase) and weeks 12, 20 (boosting phase). Personalized vaccines will consist of several distinct peptides (the dose is 0.3 mg/peptide) that are grouped into 2-4 pools and 0.5 mg of poly-ICLC as the adjuvant for each pool. Injection sites will be 2-4 separate sites of the subject's thighs.
Eligibility Criteria
You may qualify if:
- Pathologic diagnosis of pancreatic ductal adenocarcinoma
- Aged ≥20 and ≤75
- Male or not pregnant women
- Undergone radical resection (R0 status of resection margins \[no cancer cells within 1 mm of all resection margins\])
- No serious underlying disease, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No chemotherapy or radiotherapy before resection surgery
- No significant cardiac, lung, liver, kidney, and bone marrow insufficiency
- No HIV or syphilis infection
- Signing informed consent
You may not qualify if:
- Poor postoperative situation
- Obvious organ dysfunction
- Radiographically confirmed recurrence or metastasis within 180 days after the surgery
- Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmias, Myocardial infarction in the past 6 months, and prolonged QT interval (\> 450ms)
- Previous malignant tumors other than pancreatic cancer
- Cannot be follow up
- Participating in other clinical trials
- Without chemotherapy after resection surgery
- Exit criteria:
- Missed within one month after surgery or not follow-up as required
- Patient's own willingness to withdraw
- Concurrent disease or severe adverse events
- Protocol violations
- Administrative reasons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gang Jin, Doctor
Changhai Hospital, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2018
First Posted
June 15, 2018
Study Start
July 12, 2018
Primary Completion
November 30, 2023
Study Completion
December 30, 2023
Last Updated
April 24, 2023
Record last verified: 2023-03