Clinical trial · Interventional
Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer
Phase Ⅰ/Ⅱ Trial of Human Leukocyte Antigen (HLA)-A*2402-Restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Gemcitabine for Advanced Pancreatic Cancer
- 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)
Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients. Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively. HLA-A\*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Neoplasms | Pancreatic Neoplasm | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VEGFR1-A24-1084 (SYGVLLWEI) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Biological: VEGFR1-A24-1084 (SYGVLLWEI)
Primary outcomes (1)
- measure
- PhaseⅠ; safety (NCI CTCAE v.3) PhaseⅡ；time to progression (RECIST)
- timeFrame
- 1 year
Secondary outcomes (2)
- measure
- Immune response (ELISPOT, Perforin/FoxP3 FACS, in vitro CTL assay etc.)
- timeFrame
- 1 year
- measure
- Tumor regression(Imaging study, tumor marker, etc.)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Heterozygote or homozygote of HLA-A\*2402 allele * Inoperable or recurrent pancreatic cancer with or without any prior therapy * Difficult to continue the prior therapy due to treatment-related toxicities * ECOG performance status 0-2 * Evaluable primary or metastatic lesion with RECIST criteria * Clearance period from prior therapy more than 4 weeks * Life expectancy more than 3 months * Laboratory values as follows 2,000/μL\<WBC\<15,000/μL Platelet count\>100,000/μL AST\<150IU/L ALT\<150IU/L Total bilirubin\<3.0mg/dl Serum creatinine\<3.0mg/dl Exclusion Criteria: * Pregnancy (refusal or inability to use effective contraceptives) * Breastfeeding * Active or uncontrolled infection * Systemic use of corticosteroids or immunosuppressants * Uncontrollable brain metastasis and/or meningeal infiltration * Unhealed external wound * Possibilities of complicated paralytic ileus or interstitial pneumonitis * Decision of not eligible determined by principal investigator or attending doctor
References
Publications (2)
- BACKGROUNDIshizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750. PMID 17020992
- BACKGROUNDNagayama H, Sato K, Morishita M, Uchimaru K, Oyaizu N, Inazawa T, Yamasaki T, Enomoto M, Nakaoka T, Nakamura T, Maekawa T, Yamamoto A, Shimada S, Saida T, Kawakami Y, Asano S, Tani K, Takahashi TA, Yamashita N. Results of a phase I clinical study using autologous tumour lysate-pulsed monocyte-derived mature dendritic cell vaccinations for stage IV malignant melanoma patients combined with low dose interleukin-2. Melanoma Res. 2003 Oct;13(5):521-30. doi: 10.1097/00008390-200310000-00011. PMID 14512794