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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Capital Medical University
Sponsor:
Information provided by (Responsible Party):
Jun Ren MD, PhD, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01783951
First received: February 1, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK) for advanced gastric cancer.


Condition Intervention Phase
Gastric Cancer
Other: S-1 plus DC-CIK
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • Progression free survival(PFS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment.


Estimated Enrollment: 70
Study Start Date: February 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-1 plus DC-CIK

Chemotherapy: S-1 is administered orally twice daily at a dose of 80,100, or 120mg/day for body surface areas of less than 1.25m2, between 1.25m2 and less than 1.5, or 1.5m2 or greater, respectively, for 14 consecutive days, followed by a 7-day rest, repeated every 3 weeks.

DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition aphaeresis 3 days before administrating S-1 , and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times.

Other: S-1 plus DC-CIK

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783951

Contacts
Contact: Jun Ren, MD, PhD 86-10-63926317 renjun9688@yahoo.com

Locations
China, Beijing
Capital Medical University Cancer Center Recruiting
Beijing, Beijing, China, 100038
Contact: Jun Ren, MD,PhD    86-10-63926317    renjun9688@yahoo.com   
Sponsors and Collaborators
Capital Medical University
  More Information

No publications provided

Responsible Party: Jun Ren MD, PhD, Director,Capital Medical University (CMU)Cancer Center, Capital Medical University
ClinicalTrials.gov Identifier: NCT01783951     History of Changes
Other Study ID Numbers: S1+DC CIK- G
Study First Received: February 1, 2013
Last Updated: February 1, 2013
Health Authority: China: Ethics Committee

Keywords provided by Capital Medical University:
Gastric cancer
S-1
DC-CIK

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on November 25, 2014