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

August 19, 2015 updated by: Zhaoshen Li, Changhai Hospital
The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined gemcitabine therapy on advanced pancreatic cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

187

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital, Second Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Drug: Gemcitabine
standard Gemcitabine therapy
Other: iAPA-DC/CTL adoptive cellular immunotherapy
twice DC cell infusion and CTL cell infusion for 6 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month SR
Time Frame: 6 months
6 months survival rate
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 months
progression-Free Survival
6 months
OS
Time Frame: 6 months
Over survival
6 months
ORR
Time Frame: 2 months
Objective Response Rate
2 months
QOL
Time Frame: 2 months
Quality of Life
2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
Serum tumor biomarker
Time Frame: 2 months
CA19-9,CEA
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

ImmunoGene Biotechology Co.,Ltd

Investigators

  • Principal Investigator: Zhaoshen Ii, MD, Changhai Hosptial,Second Military medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 20, 2015

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cellular immunotherapy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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