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

Naval Military Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Carcinoma, Pancreatic Ductal

Treatments: Drug: Gemcitabine; Other: iAPA-DC/CTL adoptive cellular immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02529579

cellular immunotherapy

Details and patient eligibility

About

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

Enrollment: 187 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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187 participants in 2 patient groups

Gemcitabine

Active Comparator group

Description:

Standard Gemcitabine Therapy

Treatment:

Drug: Gemcitabine

cellular immunotherapy & Gemcitabine

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Other: iAPA-DC/CTL adoptive cellular immunotherapy