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

NCT01897636 | Unknown DMC

• 1 other identifier: zkx12019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Cancer

Keywords

endoscopic ultrasound-guided fine-needle injection; dendritic cell; vaccination

Outcome Measures

Primary Outcomes (1)

• pancreatic tumor response rates

  six months

Secondary Outcomes (1)

• survival rates

  six month

Study Arms (1)

EUS-guided fine-needle injection of DCs vaccinations

EXPERIMENTAL

Procedure: EUS-guided fine-needle injection of DCs vaccinations

Interventions

EUS-guided fine-needle injection of DCs vaccinations PROCEDURE

EUS-guided fine-needle injection of DCs vaccinations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum-Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Xiaoping Zou, PhD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

Central Study Contacts

Ying Lv, MD

CONTACT

86-13770755008; 13770755008@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 12, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 12, 2013

Record last verified: 2013-06

Locations

CN (1)