NCT02929797

Brief Summary

A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2016

Typical duration for early_phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 7, 2016

Last Update Submit

October 10, 2016

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    1 year

Secondary Outcomes (3)

  • Overall Survival

    3 years

  • immune indices

    1 year

  • Quality of life

    3 years

Study Arms (2)

AKT + gemcitabine

EXPERIMENTAL

gemcitabine dose 1000mg/M\^2, d1,8,15，q4w ×6 AKT 5\*10\^8/M\^2, d16,q4w ×6 Drug: gemcitabine Biological: AKT, CD8+NKG2D+ AKT Cell

Biological: CD8+NKG2D+ AKT CellDrug: Gemcitabine

gemcitabine

ACTIVE COMPARATOR

gemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine

Drug: Gemcitabine

Interventions

CD8+NKG2D+ AKT CellBIOLOGICAL

AKT: CD8+NKG2D+ AKT cell

Also known as: AKT
AKT + gemcitabine
GemcitabineDRUG

gemcitabine

Also known as: GEM
AKT + gemcitabinegemcitabine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Diagnosed as stage II-III pancreatic ductal adenocarcinoma patients by pathologic histology;
  • \. Pancreatic cancer after radical resection;
  • \. Eastern Cooperative Oncology Group Performance Status less than 2;
  • \. Without radiotherapy or neoadjuvant chemotherapy;
  • \. The man or the gestation and lactation women Age between 18 to 80 years old;
  • \. Bone marrow functioned well: ANC more than 1.5\*10\^9/ L, PLT more than 100\*10\^9/LHgb more than 9 g/dL;
  • \. Blood biochemical indicators: AST（SGOT）less than 1.5 ULNALT（SGPT）less than 1.5 ULN, TBIL less than 1.5 ULN;
  • \. PT and PPT are in normal ranges;
  • \. Three months prior to clinical research did not receive any other clinical research trials;
  • \. patients are voluntary, and willing to sign informed consent.

You may not qualify if:

  • \. Patients with other malignant tumors in the past five years;
  • \. Active viral or bacterial infection and cannot be controlled with appropriate anti-infection treatment;
  • \. Known as HIV infection, active hepatitis B virus or hepatitis C virus infection;
  • \. Known allergy to any kind of component of study drugs;
  • \. History of connective tissue disease(Such as lupus, scleroderma, nodular arteritis);
  • \. Patients with a history of interstitial pneumoniaSlowly progressive difficulty in breathing and hoose Sarcoidosissilicosis Fibrose pulmonaire idiopathiquehylactic pneumonia or A variety of allergy;
  • \. Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not cope with study treatment and monitoring requirements;
  • \. At the same time Patients participate in any other use of interventional medicine clinical research or checkers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 201620, China

RECRUITING

Shanghai General Hospital

Shanghai, 201620, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • hongxia Wang, Dr.

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hongxia Wang, Dr.

CONTACT

8621-63240090whx365@126.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Oncology

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 11, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2019

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

CN(2)