Clinical trial NCT01897636: Efficacy and Safety of Endoscopic Ultrasound Guided Fine-needle Injection of Dendritic Cells Vaccination Into Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Keywords: endoscopic ultrasound-guided fine-needle injection
dendritic cell
vaccination
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: pancreatic tumor response rates
timeFrame: six months
Secondary outcomes:
measure: survival rates
timeFrame: six month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum-Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Xiaoping Zou, PhD
role: STUDY_CHAIR
References: