NCT03002831

Brief Summary

The purpose of this study is to determine whether Cytokine induced killer cells combined chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

April 2, 2020

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

December 19, 2016

Last Update Submit

March 31, 2020

Conditions

Advanced Cancer

Keywords

CIKChemotherapyPancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    From the date of randomization to the date of death from any cause up to 36 months

Secondary Outcomes (2)

  • Progression Free Survival

    From the date of randomization to the date of first documented progression up to 24 months

  • Quality of life assessed by Questionnaire

    one year by questionnaire

Study Arms (2)

CIK combined chemotherapy

EXPERIMENTAL

Autologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour.

Biological: Cytokine-induced Killer CellsDrug: Tegafur-Gimeracil-Oteracil Potassium

Chemotherapy

ACTIVE COMPARATOR

Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w

Drug: Tegafur-Gimeracil-Oteracil Potassium

Interventions

Cytokine-induced Killer CellsBIOLOGICAL
CIK combined chemotherapy
Tegafur-Gimeracil-Oteracil PotassiumDRUG
CIK combined chemotherapyChemotherapy

Eligibility Criteria

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

You may qualify if:

  • No less than 18 years old
  • Karnofsky Performance Status over 60
  • Life expectancy more than three months
  • Pathological diagnosed as pancreatic epithelial cell carcinoma
  • Recurrence after surgery or unresectable
  • No experienced chemotherapy or the interval between the last adjuvant chemotherapy and relapse is at least 6 months
  • Measurable lesions (by CT or MRI)
  • No serious mental disorders
  • Adequate organ and bone marrow functions
  • No other serious and the conflict diseases(such as autoimmune diseases, immunodeficiency, organ transplantation)
  • No other malignant tumor history
  • Informed consent and willing to participate in this study

You may not qualify if:

  • Received immunosuppressants or glucocorticoid treatment
  • Uncontrolled severe infection or unhealed wound caused by suppurative inflammation
  • Heart disease, insufficient heart function, II degree heart block or occurred myocardial infarction in 6 months
  • Poor pulmonary functions caused by interstitial lung disease and pulmonary reserve volume under 80% of the expected value
  • Other malignant tumor history
  • Transaminase\>2.5ULN or bilirubin\>3ULN or creatinine \>1.25ULN
  • Pregnant or lactating women
  • Obvious bleeding tendency
  • Participated other clinical trails in 1 month
  • Other unsuitable conditions: HIV infection, intravenous drug abusers, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Related Publications (2)

  • Imaoka H, Kou T, Tanaka M, Egawa S, Mizuno N, Hijioka S, Hara K, Yazumi S, Shimizu Y, Yamao K. Clinical outcome of elderly patients with unresectable pancreatic cancer treated with gemcitabine plus S-1, S-1 alone, or gemcitabine alone: Subgroup analysis of a randomised phase III trial, GEST study. Eur J Cancer. 2016 Feb;54:96-103. doi: 10.1016/j.ejca.2015.11.002. Epub 2015 Dec 30.

    PMID: 26741729RESULT

  • Wang Z, Liu Y, Li R, Shang Y, Zhang Y, Zhao L, Li W, Yang Y, Zhang X, Yang T, Nie C, Han F, Liu Y, Luo S, Gao Q, Song Y. Autologous cytokine-induced killer cell transfusion increases overall survival in advanced pancreatic cancer. J Hematol Oncol. 2016 Feb 3;9:6. doi: 10.1186/s13045-016-0237-6.

    PMID: 26842696RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Quanli Gao, Ph.D.

    Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 26, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

April 2, 2020

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)