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

NCT ID: NCT02529579

Last Updated: 2015-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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Conditions

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Carcinoma, Pancreatic Ductal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Gemcitabine

Standard Gemcitabine Therapy

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

standard Gemcitabine therapy

cellular immunotherapy & Gemcitabine

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

Group Type EXPERIMENTAL

iAPA-DC/CTL adoptive cellular immunotherapy

Intervention Type OTHER

twice DC cell infusion and CTL cell infusion for 6 times

Gemcitabine

Intervention Type DRUG

standard Gemcitabine therapy

Interventions

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iAPA-DC/CTL adoptive cellular immunotherapy

twice DC cell infusion and CTL cell infusion for 6 times

Intervention Type OTHER

Gemcitabine

standard Gemcitabine therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ImmunoGene Biotechology Co.,Ltd

UNKNOWN

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

director of department of gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaoshen Ii, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hosptial,Second Military medical University

Locations

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Changhai Hospital, Second Military Medical University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaoshen Li, MD

Role: CONTACT

+86-21-25070552

Jun Gao, PhD

Role: CONTACT

+86-13816012151

Facility Contacts

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zhaoshen Li, MD

Role: primary

86-21-81873241

Other Identifiers

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cellular immunotherapy

Identifier Type: -

Identifier Source: org_study_id

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