Efficacy and Safety of Endoscopic Ultrasound Guided Fine-needle Injection of Dendritic Cells Vaccination Into Unresectable Pancreatic Cancer

Not Applicable

• Conditions: Pancreatic Cancer
• Interventions: Procedure: EUS-guided fine-needle injection of DCs vaccinations

• Registration Number: NCT01897636
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-06
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-09
• Study First Posted: 2013-07-12
• Last Update Posted: 2013-07-12
• Study Start: 2013-12
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS-guided fine-needle injection of DCs vaccinations	EUS-guided fine-needle injection of DCs vaccinations	-

Primary Outcome Measures

Name	Time	Method
pancreatic tumor response rates	six months

Secondary Outcome Measures

Name	Time	Method
survival rates	six month

Trial Locations

Locations (1)

Nanjing Drum-Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China