Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Tumor | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized neoantigen vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Personalized neoantigen vaccine
- description
- Patients will receive radical resection surgery and at least one circle of post-operative chemotherapy. After chemotherapy, personalized neoantigen vaccines will be administered subcutaneously.
- interventionNames
- Biological: Personalized neoantigen vaccine
Primary outcomes (1)
- measure
- Incidence and grades of adverse events as assessed by CTCAE v5.0
- timeFrame
- From the first dose of vaccination through 2 years after the surgery
- description
- 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).
Secondary outcomes (3)
- measure
- Recurrence-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available