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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02529579

Enrollment

187

Registered

2015-08-20

Start date

2015-06-30

Completion date

2019-12-31

Last updated

2015-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Pancreatic Ductal

Keywords

adoptive Cellular Immunotherapy, patient safety, therapeutic effect

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.

Interventions

OTHERiAPA-DC/CTL adoptive cellular immunotherapy

twice DC cell infusion and CTL cell infusion for 6 times

DRUGGemcitabine

standard Gemcitabine therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
6-month SR	6 months	6 months survival rate

Secondary

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

Other

Measure	Time frame	Description
Serum tumor biomarker	2 months	CA19-9,CEA
immunological markers	2 months	CD3, CD4,CD8,CD16,CD56,CD45,Treg(CD4,CD25, CD127low), IL-1B,IL-2R, IL-10,TNF-a，

Countries

China

Contacts

Primary ContactZhaoshen Li, MD

zhaoshenlismmu@gmail.com+86-21-25070552

Backup ContactJun Gao, PhD

13816012151@163.com+86-13816012151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026