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Trial Title:
Efficacy and Safety of Endoscopic Ultrasound Guided Fine-needle Injection of Dendritic Cells Vaccination Into Unresectable Pancreatic Cancer
NCT ID:
NCT01897636
Condition:
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
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
EUS-guided fine-needle injection of DCs vaccinations
Arm group label:
EUS-guided fine-needle injection of DCs vaccinations
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanjing Drum-Tower Hospital
Address:
City:
Nanjing
Zip:
210008
Country:
China
Contact:
Last name:
Ying Lv, MD
Phone:
86-13770755008
Email:
13770755008@126.com
Start date:
December 2013
Completion date:
March 2017
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01897636
