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Trial record 32 of 52 for:    Recruiting, Not yet recruiting, Available Studies | "Patient Safety"

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

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ClinicalTrials.gov Identifier: NCT02529579
Recruitment Status : Recruiting
First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Collaborator:
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

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 ]
    CA19-9,CEA



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02529579


Contacts
Contact: Zhaoshen Li, MD +86-21-25070552 zhaoshenlismmu@gmail.com
Contact: Jun Gao, PhD +86-13816012151 13816012151@163.com

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

Responsible Party: Zhaoshen Li, director of department of gastroenterology, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02529579     History of Changes
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:
Carcinoma, Pancreatic Ductal
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs