NCT02529579

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
187

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 20, 2015

Status Verified

January 1, 2015

Enrollment Period

3.5 years

First QC Date

August 18, 2015

Last Update Submit

August 19, 2015

Conditions

Carcinoma, Pancreatic Ductal

Keywords

adoptive Cellular Immunotherapypatient safetytherapeutic effect

Outcome Measures

Primary Outcomes (1)

  • 6-month SR

    6 months survival rate

    6 months

Secondary Outcomes (4)

  • PFS

    6 months

  • OS

    6 months

  • ORR

    2 months

  • QOL

    2 months

Other Outcomes (2)

  • immunological markers

    2 months

  • Serum tumor biomarker

    2 months

Study Arms (2)

Gemcitabine

ACTIVE COMPARATOR

Standard Gemcitabine Therapy

Drug: Gemcitabine

cellular immunotherapy & Gemcitabine

EXPERIMENTAL

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

Other: iAPA-DC/CTL adoptive cellular immunotherapyDrug: Gemcitabine

Interventions

iAPA-DC/CTL adoptive cellular immunotherapyOTHER

twice DC cell infusion and CTL cell infusion for 6 times

cellular immunotherapy & Gemcitabine
GemcitabineDRUG

standard Gemcitabine therapy

Gemcitabinecellular immunotherapy & Gemcitabine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Zhaoshen Ii, MD

    Changhai Hosptial,Second Military medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoshen Li, MD

CONTACT

+86-21-25070552zhaoshenlismmu@gmail.com

Jun Gao, PhD

CONTACT

+86-1381601215113816012151@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of department of gastroenterology

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 20, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

August 20, 2015

Record last verified: 2015-01

Locations

CN(1)