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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Biological: DC-CIK Drug: S-1 Drug: Cisplatin Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Dendritic Cell-cytokine Induced Killer Cell Immunotherapy Combined With S-1 Based Chemotherapy in Patients With Advanced Gastric Cancer
Actual Study Start Date : February 1, 2013
Actual Primary Completion Date : February 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival（PFS） [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]
  2. Response rate [ Time Frame: Every 6 weeks ]
  3. Adverse Events [ Time Frame: Every 3 weeks ]
  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783951


Locations
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China, Beijing
Capital Medical University Cancer Center
Beijing, Beijing, China, 100038
Sponsors and Collaborators
Capital Medical University
Duke University
Geneplus-Beijing Co. Ltd.
More Information
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Responsible Party: Jun Ren MD, PhD, Director,Capital Medical University (CMU)Cancer Center, Capital Medical University
ClinicalTrials.gov Identifier: NCT01783951    
Other Study ID Numbers: S1+DC CIK- G
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun Ren MD, PhD, Capital Medical University:
Gastric cancer
S-1
DC-CIK
T cell
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Antineoplastic Agents