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Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01783951
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : July 19, 2018
Sponsor:
Collaborators:
Duke University
Geneplus-Beijing Co. Ltd.
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University

Tracking Information
First Submitted Date  ICMJE February 1, 2013
First Posted Date  ICMJE February 5, 2013
Last Update Posted Date July 19, 2018
Actual Study Start Date  ICMJE February 1, 2013
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2013)
Progression free survival(PFS) [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2013)
  • Overall survival [ Time Frame: 4 years ]
  • Response rate [ Time Frame: Every 6 weeks ]
  • Adverse Events [ Time Frame: Every 3 weeks ]
  • Quality of life [ Time Frame: 6 weeks ]
    Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer
Official Title  ICMJE Autologous Dendritic Cell-cytokine Induced Killer Cell Immunotherapy Combined With S-1 Based Chemotherapy in Patients With Advanced Gastric Cancer
Brief Summary The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness dendritic cell activated Cytokine induced killer treatment (DC-CIK) plus S-1 based chemotherapy for advanced gastric cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Biological: DC-CIK
    Patients will be receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.
  • Drug: S-1
    The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25 to <1.5 m2, 50 mg; and ≥1.5 m2, 60 mg, given twice daily after meals for 14 days followed by 7 days rest.
  • Drug: Cisplatin
    Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.
Study Arms  ICMJE
  • Experimental: DC-CIK plus S-1 based chemotherapy
    Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone. Meanwhile those patients will receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.
    Interventions:
    • Biological: DC-CIK
    • Drug: S-1
    • Drug: Cisplatin
  • Active Comparator: S-1 based chemotherapy
    Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone.Cycles were repeated every 21 days. Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.
    Interventions:
    • Drug: S-1
    • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2018)
63
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2013)
70
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma
  • Between 18 and 80 years old
  • Capable of oral intake
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Karnofsky Performance Status (KPS) ≥ 70%
  • Normal functions of heart, lung and bone marrow
  • Adequate hematological profile: Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3
  • Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
  • Adequate renal function(normal serum creatinine level)
  • A life expectancy≥ 2 months
  • Informed consent signed

Exclusion Criteria:

  • Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study
  • Any radiotherapy or surgery within the previous 4 weeks
  • Symptomatic brain metastasis not controlled by corticosteroids
  • Bone marrow metastasis
  • Active infection
  • Serious complications
  • Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.
  • Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
  • Ineligible for the study at the discretion of investigators
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01783951
Other Study ID Numbers  ICMJE S1+DC CIK- G
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jun Ren MD, PhD, Capital Medical University
Study Sponsor  ICMJE Capital Medical University
Collaborators  ICMJE
  • Duke University
  • Geneplus-Beijing Co. Ltd.
Investigators  ICMJE Not Provided
PRS Account Capital Medical University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP