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Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer

Primary Purpose

Advanced Cancer

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cytokine-induced Killer Cells
Tegafur-Gimeracil-Oteracil Potassium
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring CIK, Chemotherapy, Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CIK combined chemotherapy

Chemotherapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression Free Survival
Quality of life assessed by Questionnaire

Full Information

First Posted
December 19, 2016
Last Updated
March 31, 2020
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03002831
Brief Title
Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer
Official Title
Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer: A Prospective, Randomized, Open, Single Center Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Study halted prematurely and will not resume
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Pancreatic cancer is a devastating malignant disease with a median survival of 3-6 months and a 5-year survival rate of less than 5%. It is necessary to explore more treatment mode to pancreatic cancer especially advanced stage patients. This study is a prospective, randomized, open, single center phase II study. The investigators try to evaluate the efficacy and safety of this treatment mode.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer
Keywords
CIK, Chemotherapy, Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CIK combined chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w
Intervention Type
Biological
Intervention Name(s)
Cytokine-induced Killer Cells
Intervention Type
Drug
Intervention Name(s)
Tegafur-Gimeracil-Oteracil Potassium
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
From the date of randomization to the date of death from any cause up to 36 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
From the date of randomization to the date of first documented progression up to 24 months
Title
Quality of life assessed by Questionnaire
Time Frame
one year by questionnaire

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quanli Gao, Ph.D.
Organizational Affiliation
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26741729
Citation
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.
Results Reference
result
PubMed Identifier
26842696
Citation
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.
Results Reference
result

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Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer

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