Clinical trial · Interventional
Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer
Phase I/II Study on Intratumor Dendritic Cell Injection Immunotherapy Using Immature Dendritic Cells With S Pyogenes Preparation (OK-432) for Patients With Resectable Pancreatic Cancer
NCT00795977CI-TRIAL-00005466unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to confirm safety and immunological responses of Preoperative intratumor dendritic cells injection immunotherapy using immature dendritic cells with S pyogenes Preparation (OK-432) for patients with resectable pancreatic cancer for pancreatic cancer patients.
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 Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dendritic cells, OK-432 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- dendritic cells
- interventionNames
- Biological: dendritic cells, OK-432
Primary outcomes (1)
- measure
- To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with OK-432
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- To determine the overall response rate for this regimen as determined by overall and disease-free survival.
- timeFrame
- 2 years
- measure
- To evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: Resectable pancreatic cancer without distant metastasis: 1. ECOG performance status 0-2 2. Laboratory values as follows 3,500/mm3 \<WBC\<12000/mm3 Platelet count\>100,000/mm3 T-Bil\<2.0mg/dl BUN\<25mg/dl, Creatinin\<1.5mg/dl, 24h Ccr\>50ml/min Normal ECG 3. Able and willing to give valid written informed consent Exclusion Criteria: 1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) 2. Breast-feeder 3. Active or uncontrolled infection 4. Active or uncontrolled other malignancy 5. Steroids or immunosuppressing agent dependant status 6. Interstitial pneumonia 7. Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (4)
- BACKGROUNDKanzaki N, Terashima M, Kashimura S, Hoshino M, Ohtani S, Matsuyama S, Hoshino Y, Kogure M, Oshibe I, Endo H, Saito T, Yaginuma H, Gotoh M, Ohto H. Understanding the response of dendritic cells to activation by streptococcal preparation OK-432. Anticancer Res. 2005 Nov-Dec;25(6B):4231-8. PMID 16309221
- BACKGROUNDTakekuni K, Sakon M, Kishimoto S, Amano M, Sekimoto M, Aoki T, Oosato H, Dohno K, Umeshita K, Gotoh M, Monden T, Monden M. [A patient with unresectable cancer of pancreas head, effectively treated by a local injection of the mixture of OK-432, fibrinogen and thrombin]. Gan To Kagaku Ryoho. 1996 Sep;23(11):1621-3. Japanese. PMID 8854822
- BACKGROUNDOkamoto M, Furuichi S, Nishioka Y, Oshikawa T, Tano T, Ahmed SU, Takeda K, Akira S, Ryoma Y, Moriya Y, Saito M, Sone S, Sato M. Expression of toll-like receptor 4 on dendritic cells is significant for anticancer effect of dendritic cell-based immunotherapy in combination with an active component of OK-432, a streptococcal preparation. Cancer Res. 2004 Aug 1;64(15):5461-70. doi: 10.1158/0008-5472.CAN-03-4005. PMID 15289356
- BACKGROUNDOshikawa T, Okamoto M, Ahmed SU, Tano T, Yoshida H, Sato M. [Anti-cancer effect of an intratumoral injection of dendritic cells expressing TLR4 in combination with an active component of OK-432 in TLR4-deficient mice]. Gan To Kagaku Ryoho. 2004 Oct;31(11):1770-2. Japanese. PMID 15553710