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Safety and Efficacy Evaluation of iAPA-DC/CTL Combined Gemcitabine Therapy on Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02529579
Recruitment Status : Unknown
Verified January 2015 by Zhaoshen Li, Changhai Hospital.
Recruitment status was:  Recruiting
First Posted : August 20, 2015
Last Update Posted : August 20, 2015
ImmunoGene Biotechology Co.,Ltd
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Brief Summary:
The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined gemcitabine therapy on advanced pancreatic cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Other: iAPA-DC/CTL adoptive cellular immunotherapy Drug: Gemcitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Gemcitabine
Standard Gemcitabine Therapy
Drug: Gemcitabine
standard Gemcitabine therapy

Experimental: cellular immunotherapy & Gemcitabine
iAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy
Other: iAPA-DC/CTL adoptive cellular immunotherapy
twice DC cell infusion and CTL cell infusion for 6 times

Drug: Gemcitabine
standard Gemcitabine therapy

Primary Outcome Measures :
  1. 6-month SR [ Time Frame: 6 months ]
    6 months survival rate

Secondary Outcome Measures :
  1. PFS [ Time Frame: 6 months ]
    progression-Free Survival

  2. OS [ Time Frame: 6 months ]
    Over survival

  3. ORR [ Time Frame: 2 months ]
    Objective Response Rate

  4. QOL [ Time Frame: 2 months ]
    Quality of Life

Other Outcome Measures:
  1. immunological markers [ Time Frame: 2 months ]
    CD3, CD4,CD8,CD16,CD56,CD45,Treg(CD4,CD25, CD127low), IL-1B,IL-2R, IL-10,TNF-a,

  2. Serum tumor biomarker [ Time Frame: 2 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Advanced Pancreatic cancer patients with histological pathology confirmation
  2. Both gender, aged 18-70 year-old
  3. Bone marrow functioned well
  4. Renal function normal
  5. Liver function normal
  6. patients are voluntary, and willing to sign informed consent
  7. expected lifetime was at least 3 months

Exclusion Criteria:

  1. With acute inflammation
  2. Accompanied with primary malignant tumor other than pancreas
  3. with autoimmune disease
  4. using corticosteroid or other suppress immune hormone treatment
  5. had transplant operation of vital organs
  6. active hepatitis
  7. HIV positive
  8. dysfunction in blood coagulation
  9. serious diseases in circulatory and respiratory systems
  10. pregnancy or breast-feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02529579

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Contact: Zhaoshen Li, MD +86-21-25070552
Contact: Jun Gao, PhD +86-13816012151

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Changhai Hospital, Second Military Medical University Recruiting
Shanghai, China, 200433
Contact: zhaoshen Li, MD    86-21-81873241   
Principal Investigator: zhaoshen Li, MD         
Sponsors and Collaborators
Changhai Hospital
ImmunoGene Biotechology Co.,Ltd
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Principal Investigator: Zhaoshen Ii, MD Changhai Hosptial,Second Military medical University

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Responsible Party: Zhaoshen Li, director of department of gastroenterology, Changhai Hospital Identifier: NCT02529579    
Other Study ID Numbers: cellular immunotherapy
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: January 2015
Keywords provided by Zhaoshen Li, Changhai Hospital:
adoptive Cellular Immunotherapy
patient safety
therapeutic effect
Additional relevant MeSH terms:
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Carcinoma, Pancreatic Ductal
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Immunologic Factors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Physiological Effects of Drugs