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

Carcinoma, Pancreatic Ductal Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02529579
• Other study ID #: cellular immunotherapy
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 18, 2015
• Last updated: August 19, 2015
• Start date: June 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2015
• Source: Changhai Hospital
• Contact: Zhaoshen Li, MD
• Phone: +86-21-25070552
• Email: zhaoshenlismmu[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 187
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Pancreatic Ductal

Intervention

Other:
• iAPA-DC/CTL adoptive cellular immunotherapy
twice DC cell infusion and CTL cell infusion for 6 times

Drug:
• Gemcitabine
standard Gemcitabine therapy

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Changhai Hospital	ImmunoGene Biotechology Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	immunological markers	CD3, CD4,CD8,CD16,CD56,CD45,Treg(CD4,CD25, CD127low), IL-1B,IL-2R, IL-10,TNF-a,	2 months	No
Other	Serum tumor biomarker	CA19-9,CEA	2 months	No
Primary	6-month SR	6 months survival rate	6 months	Yes
Secondary	PFS	progression-Free Survival	6 months	No
Secondary	OS	Over survival	6 months	No
Secondary	ORR	Objective Response Rate	2 months	No
Secondary	QOL	Quality of Life	2 months	No