Safety and Efficacy Evaluation of iAPA-DC/CTL Combined Ge... | NCT02529579

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

NCT02529579

Sponsor

Changhai Hospital

Status

Unknown status

Last Update Posted

Aug 20, 2015Estimated

Enrollment

187Estimated

Phase

Phase 1Phase 2

Conditions

Carcinoma, Pancreatic Ductal

Interventions

iAPA-DC/CTL adoptive cellular immunotherapy
Gemcitabine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Aug 18, 2015

First Submission Date that Met QC Criteria

Aug 19, 2015

First Posted Date

Aug 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2015

Last Update Posted Date

Aug 20, 2015Estimated

Name	Class
ImmunoGene Biotechology Co.,Ltd	UNKNOWN

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

187Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gemcitabine	Active Comparator	Standard Gemcitabine Therapy	Drug: Gemcitabine
cellular immunotherapy & Gemcitabine	Experimental	iAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy	Other: iAPA-DC/CTL adoptive cellular immunotherapy Drug: Gemcitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iAPA-DC/CTL adoptive cellular immunotherapy	Other	twice DC cell infusion and CTL cell infusion for 6 times	cellular immunotherapy & Gemcitabine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
PFS	progression-Free Survival	6 months
OS	Over survival	6 months

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced Pancreatic cancer patients with histological pathology confirmation
Both gender, aged 18-70 year-old
Bone marrow functioned well
Renal function normal
Liver function normal
patients are voluntary, and willing to sign informed consent
expected lifetime was at least 3 months

Exclusion Criteria:

With acute inflammation
Accompanied with primary malignant tumor other than pancreas
with autoimmune disease
using corticosteroid or other suppress immune hormone treatment
had transplant operation of vital organs
active hepatitis
HIV positive
dysfunction in blood coagulation
serious diseases in circulatory and respiratory systems
pregnancy or breast-feeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhaoshen Li, MD	Contact	+86-21-25070552		zhaoshenlismmu@gmail.com
Jun Gao, PhD	Contact	+86-13816012151		13816012151@163.com

Overall Officials

Name	Affiliation	Role
Zhaoshen Ii, MD	Changhai Hosptial,Second Military medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changhai Hospital, Second Military Medical University	Recruiting	Shanghai		200433	China

Condition Browse Module

MeSH Terms

ID	Term
D021441	Carcinoma, Pancreatic Ductal

Ancestor Terms

ID	Term
D044584	Carcinoma, Ductal
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided