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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DC-CIK
S-1
Cisplatin
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, S-1, DC-CIK, T cell

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Capital Medical University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DC-CIK plus S-1 based chemotherapy

S-1 based chemotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression free survival（PFS）

Secondary Outcome Measures

Overall survival
Response rate
Adverse Events
Quality of life
Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.

Full Information

First Posted
February 1, 2013
Last Updated
July 18, 2018
Sponsor
Capital Medical University
Collaborators
Duke University, Geneplus-Beijing Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01783951
Brief Title
Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer
Official Title
Autologous Dendritic Cell-cytokine Induced Killer Cell Immunotherapy Combined With S-1 Based Chemotherapy in Patients With Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
Collaborators
Duke University, Geneplus-Beijing Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, S-1, DC-CIK, T cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DC-CIK plus S-1 based chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
S-1 based chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
DC-CIK
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.
Primary Outcome Measure Information:
Title
Progression free survival（PFS）
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
4 years
Title
Response rate
Time Frame
Every 6 weeks
Title
Adverse Events
Time Frame
Every 3 weeks
Title
Quality of life
Description
Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Capital Medical University Cancer Center
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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