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

Primary Purpose

Carcinoma, Pancreatic Ductal

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
iAPA-DC/CTL adoptive cellular immunotherapy
Gemcitabine
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Pancreatic Ductal focused on measuring adoptive Cellular Immunotherapy, patient safety, therapeutic effect

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changhai Hospital, Second Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gemcitabine

cellular immunotherapy & Gemcitabine

Arm Description

Standard Gemcitabine Therapy

iAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy

Outcomes

Primary Outcome Measures

6-month SR
6 months survival rate

Secondary Outcome Measures

PFS
progression-Free Survival
OS
Over survival
ORR
Objective Response Rate
QOL
Quality of Life

Full Information

First Posted
August 18, 2015
Last Updated
August 19, 2015
Sponsor
Changhai Hospital
Collaborators
ImmunoGene Biotechology Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02529579
Brief Title
Safety and Efficacy Evaluation of iAPA-DC/CTL Combined Gemcitabine Therapy on Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
ImmunoGene Biotechology Co.,Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Pancreatic Ductal
Keywords
adoptive Cellular Immunotherapy, patient safety, therapeutic effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
187 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine
Arm Type
Active Comparator
Arm Description
Standard Gemcitabine Therapy
Arm Title
cellular immunotherapy & Gemcitabine
Arm Type
Experimental
Arm Description
iAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy
Intervention Type
Other
Intervention Name(s)
iAPA-DC/CTL adoptive cellular immunotherapy
Intervention Description
twice DC cell infusion and CTL cell infusion for 6 times
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
standard Gemcitabine therapy
Primary Outcome Measure Information:
Title
6-month SR
Description
6 months survival rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PFS
Description
progression-Free Survival
Time Frame
6 months
Title
OS
Description
Over survival
Time Frame
6 months
Title
ORR
Description
Objective Response Rate
Time Frame
2 months
Title
QOL
Description
Quality of Life
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
immunological markers
Description
CD3, CD4,CD8,CD16,CD56,CD45,Treg(CD4,CD25, CD127low), IL-1B,IL-2R, IL-10,TNF-a，
Time Frame
2 months
Title
Serum tumor biomarker
Description
CA19-9,CEA
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced Pancreatic cancer patients with histological pathology confirmation Both gender, aged 18-70 year-old Bone marrow functioned well Renal function normal Liver function normal patients are voluntary, and willing to sign informed consent expected lifetime was at least 3 months Exclusion Criteria: With acute inflammation Accompanied with primary malignant tumor other than pancreas with autoimmune disease using corticosteroid or other suppress immune hormone treatment had transplant operation of vital organs active hepatitis HIV positive dysfunction in blood coagulation serious diseases in circulatory and respiratory systems pregnancy or breast-feeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaoshen Li, MD
Phone
+86-21-25070552
Email
zhaoshenlismmu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Gao, PhD
Phone
+86-13816012151
Email
13816012151@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Ii, MD
Organizational Affiliation
Changhai Hosptial,Second Military medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhaoshen Li, MD
Phone
86-21-81873241
Email
zhaoshenlismmu@gmail.com
First Name & Middle Initial & Last Name & Degree
zhaoshen Li, MD

12. IPD Sharing Statement

Learn more about this trial

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

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