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

Phase 1

• Conditions: Carcinoma, Pancreatic Ductal
• Interventions: Drug: Gemcitabine; Other: iAPA-DC/CTL adoptive cellular immunotherapy

• Registration Number: NCT02529579
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-01
• Study Start: 2015-06
• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-19
• Last Update Submitted: 2015-08-19
• Study First Posted: 2015-08-20
• Last Update Posted: 2015-08-20
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 187

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine	Gemcitabine	Standard Gemcitabine Therapy
cellular immunotherapy & Gemcitabine	iAPA-DC/CTL adoptive cellular immunotherapy	iAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy
cellular immunotherapy & Gemcitabine	Gemcitabine	iAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy

Primary Outcome Measures

Name	Time	Method
6-month SR	6 months	6 months survival rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China