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Efficacy and Safety of Endoscopic Ultrasound Guided Fine-needle Injection of Dendritic Cells Vaccination Into Unresectable Pancreatic Cancer
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
endoscopic ultrasound-guided fine-needle injection, dendritic cell, vaccination
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: EUS-guided fine-needle injection of DCs vaccinations
Type: Procedure
Overall Status
Not yet recruiting
Summary
Pancreatic cancer is the second most frequent gastrointestinal malignancy. The overall survival is dismal. Especially for advanced pancreatic cancer, the conventional approaches are typically not curative and provide only minor increases in survivals in most cases. Dendritic cells (DCs) are powerful antigen-presenting cells (APCs) that play a pivotal role in the initiation, programming, and regulation of tumor-specific immune responses. Isolated DCs loaded with tumor antigen ex vivo and administered as a cellular vaccine have been found to induce protective and therapeutic anti-tumor immunity in experimental animals. Some clinical trials of DC vaccination for cancer patients have shown the induction of anti-tumor immune responses and tumor regression. Endoscopic ultrasound (EUS) is an established technique for the diagnosis and staging of pancreatic cancer. Endoscopic ultrasound guided fine-needle direct injection of dendritic cells vaccination into pancreatic tumors may be a promising treatment modality.Therefore, The purpose of the study is to evaluate the efficacy and safety of endoscopic ultrasound guided fine-needle injection of DCs vaccination into advanced pancreatic cancer
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. Histologically or cytologically confirmed adenocarcinoma of the pancreas.
2. Patients must be deemed unresectable due to involvement of important vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.
3. Life expectancy of >3 months.
4. Karnofsky performance status >50%.
5. Patients must have adequate clotting and coagulation function (platelet > 100k; INR<1.4).
6. Able and willing to sign a written informed consent.
Exclusion Criteria:
1. Patients receiving anticoagulation therapy.
2. Steroids or immunosuppressing agent dependant status
3. Patients who have received prior gemcitabine or radiation therapy in the past 4 weeks
4. Ongoing infection
5. Pregnancy or breast-feeder
6. Other concurrent diseases including other malignancy,psychiatric illness,heart, lung and renal disfunctions
7. Massive ascites
8. Decision of unsuitableness by principal investigator or physician-in-charge
1. Histologically or cytologically confirmed adenocarcinoma of the pancreas.
2. Patients must be deemed unresectable due to involvement of important vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.
3. Life expectancy of >3 months.
4. Karnofsky performance status >50%.
5. Patients must have adequate clotting and coagulation function (platelet > 100k; INR<1.4).
6. Able and willing to sign a written informed consent.
Exclusion Criteria:
1. Patients receiving anticoagulation therapy.
2. Steroids or immunosuppressing agent dependant status
3. Patients who have received prior gemcitabine or radiation therapy in the past 4 weeks
4. Ongoing infection
5. Pregnancy or breast-feeder
6. Other concurrent diseases including other malignancy,psychiatric illness,heart, lung and renal disfunctions
7. Massive ascites
8. Decision of unsuitableness by principal investigator or physician-in-charge
Location
Nanjing Drum-Tower Hospital
Nanjing, Jiangsu, China
Status: Not yet recruiting
Contact: Ying Lv, MD - 86-13770755008 - 13770755008@126.com
Start Date
December 2013
Completion Date
March 2017
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Source
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page