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

• ClinicalTrials.gov Identifier: NCT01783951
• Recruitment Status: Completed
• First Posted: February 5, 2013
• Last Update Posted: July 19, 2018
• Sponsor: Capital Medical University
• Collaborators: Duke University; Geneplus-Beijing Co. Ltd.
• Information provided by (Responsible Party): Jun Ren MD, PhD, Capital Medical University

Tracking Information

• First Submitted Date: February 1, 2013
• First Posted Date: February 5, 2013
• Last Update Posted Date: July 19, 2018
• Actual Study Start Date: February 1, 2013
• Actual Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 1, 2013): Progression free survival（PFS） [ Time Frame: 4 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 18, 2018): 63
• Original Estimated Enrollment (submitted: February 1, 2013): 70
• Actual Study Completion Date: June 1, 2018
• Actual Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01783951
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Jun Ren MD, PhD, Capital Medical University
• Study Sponsor: Capital Medical University

Collaborators

• Duke University
• Geneplus-Beijing Co. Ltd.

• Investigators: Not Provided
• PRS Account: Capital Medical University
• Verification Date: July 2018