Efficacy and Safety of Endoscopic Ultrasound Guided Fine-needle Injection of Dendritic Cells Vaccination Into Unresectable Pancreatic Cancer (DC)
Primary Purpose
Pancreatic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS-guided fine-needle injection of DCs vaccinations
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring endoscopic ultrasound-guided fine-needle injection, dendritic cell, vaccination
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas.
- 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.
- Life expectancy of >3 months.
- Karnofsky performance status >50%.
- Patients must have adequate clotting and coagulation function (platelet > 100k; INR<1.4).
- Able and willing to sign a written informed consent.
Exclusion Criteria:
- Patients receiving anticoagulation therapy.
- Steroids or immunosuppressing agent dependant status
- Patients who have received prior gemcitabine or radiation therapy in the past 4 weeks
- Ongoing infection
- Pregnancy or breast-feeder
- Other concurrent diseases including other malignancy,psychiatric illness,heart, lung and renal disfunctions
- Massive ascites
- Decision of unsuitableness by principal investigator or physician-in-charge
Sites / Locations
- Nanjing Drum-Tower Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EUS-guided fine-needle injection of DCs vaccinations
Arm Description
Outcomes
Primary Outcome Measures
pancreatic tumor response rates
Secondary Outcome Measures
survival rates
Full Information
NCT ID
NCT01897636
First Posted
July 9, 2013
Last Updated
July 9, 2013
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1. Study Identification
Unique Protocol Identification Number
NCT01897636
Brief Title
Efficacy and Safety of Endoscopic Ultrasound Guided Fine-needle Injection of Dendritic Cells Vaccination Into Unresectable Pancreatic Cancer
Acronym
DC
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
endoscopic ultrasound-guided fine-needle injection, dendritic cell, vaccination
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EUS-guided fine-needle injection of DCs vaccinations
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
EUS-guided fine-needle injection of DCs vaccinations
Primary Outcome Measure Information:
Title
pancreatic tumor response rates
Time Frame
six months
Secondary Outcome Measure Information:
Title
survival rates
Time Frame
six month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the pancreas.
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.
Life expectancy of >3 months.
Karnofsky performance status >50%.
Patients must have adequate clotting and coagulation function (platelet > 100k; INR<1.4).
Able and willing to sign a written informed consent.
Exclusion Criteria:
Patients receiving anticoagulation therapy.
Steroids or immunosuppressing agent dependant status
Patients who have received prior gemcitabine or radiation therapy in the past 4 weeks
Ongoing infection
Pregnancy or breast-feeder
Other concurrent diseases including other malignancy,psychiatric illness,heart, lung and renal disfunctions
Massive ascites
Decision of unsuitableness by principal investigator or physician-in-charge
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Lv, MD
Phone
86-13770755008
Email
13770755008@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoping Zou, PhD
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Drum-Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Lv, MD
Phone
86-13770755008
Email
13770755008@126.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Endoscopic Ultrasound Guided Fine-needle Injection of Dendritic Cells Vaccination Into Unresectable Pancreatic Cancer
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