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

NCT ID: NCT01897636

Last Updated: 2013-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EUS-guided fine-needle injection of DCs vaccinations

Group Type: EXPERIMENTAL

EUS-guided fine-needle injection of DCs vaccinations

Intervention Type: PROCEDURE

Interventions

EUS-guided fine-needle injection of DCs vaccinations

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Ying Lv

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoping Zou, PhD

Role: STUDY_CHAIR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

Nanjing Drum-Tower Hospital

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Ying Lv, MD

Role: CONTACT

13770755008@126.com

86-13770755008

Facility Contacts

Ying Lv, MD

Role: primary

13770755008@126.com

86-13770755008

Other Identifiers

zkx12019

Identifier Type: -

Identifier Source: org_study_id