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DC-CIK In Combination With Chemotherapy ( Gio / Oxaliplatin or Cisplatin ) Versus First-line Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Randomized Controlled Phase II Clinical Study of Treatment

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ClinicalTrials.gov Identifier: NCT02504229
Recruitment Status : Recruiting
First Posted : July 21, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Beijing Biohealthcare Biotechnology Co.,Ltd

Brief Summary:
This study evaluates the therapeutic effects of autologous dendritic cells co-cultured with cytokine-induced killer cells (DC-CIK) combined with S-1 ((Tegafur, Gimeracil, and Oteracil Potassium) and oxaliplatin adjuvant chemotherapy in locally advanced unresectable or metastaticgastric cancer. Half of participants will receive DC-CIK combined with S-1 and oxaliplatin adjuvant chemotherapy,while the other half will receive S-1 and oxaliplatin adjuvant chemotherapy served as controls.

Condition or disease Intervention/treatment Phase
Gastric Cancer Biological: autologous dendritic cells co-cultured with cytokine-induced killer cells Drug: Gimeracil and Oteracil Porassium Capsules Drug: Oxaliplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: Chemotherapy+DC-CIK
Combined treatment group:mononuclear cells were obtained aseptically with blood cell separator composition spheresis 1 day before SOX program chemotherapy, cultured DC-CIK cells. SOX program was acted on Day 2. Cells were cultured 14d,2 times back to the patient.A 21d was a cycle, then evaluated the therapeutic effect after two cycles.
Biological: autologous dendritic cells co-cultured with cytokine-induced killer cells
Drug: Gimeracil and Oteracil Porassium Capsules
Drug: Oxaliplatin
Other Name: Eloxatin

Active Comparator: Chemotherapy alone
Chemotherapy: two groups were treated with SOX program,specific drugs:Venoclysis of oxaliplatin 130mg/㎡;Day 1; Tegafur,Gimeracil and Oteracil Porassium Capsules 80mg/㎡/d,two oral/d;Day 1 to 12; 21d as one cycle of treatment, evaluated the therapeutic effect after two cycles.
Drug: Gimeracil and Oteracil Porassium Capsules
Drug: Oxaliplatin
Other Name: Eloxatin




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age>18y;
  2. ECOG physical status 0-1;
  3. The histologic diagnosis of stomach/gastroesophageal junction adenocarcinoma;
  4. According to the RECIST 1.1 standard with measurable or evaluable lesion;
  5. Accept swallow oral drug;
  6. WBC≧4.0×10^9/L;ALC≧0.8×10^9/L;ANC≧1.5×10^9/L;PLT≧100×10^9/L;ALT,AST≦2.5 times of the normal limit;ALP≦2.5 times of the normal limit;TBIL﹤1.5 times of the normal limit;SCr﹤1 times of the normal limit;ALB≧30g/L;
  7. The expected survival time of more than 3 months;
  8. good compliance;
  9. Provide written informed consent.

Exclusion Criteria:

  1. Vital organs (heart,liver,kidney) function is serious dysfunction;
  2. Patients received organ transplantation;
  3. Patients with other malignant tumors or have occurred brain metastasis;
  4. Patients with history of autoimmune disease;
  5. Patients in pregnancy or breast-feeding period(women of child-bearing age need to check pregnancy test);
  6. Patients with acute infection disease or in chronic active stage;
  7. Patients with clear history of drug allergy or belong to allergic constitution;
  8. Patients received chemotherapy,radiation therapy, immunosuppressive drugs (cyclosporine A,etc.) or other immune treatment in 4 weeks;
  9. Patients received other clinical trials in 4 weeks.

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): NCT02504229


Contacts
Contact: Jingwei liu, PhD 13241238766 ljwgirl361@163.com
Contact: Tsai Ting Huang 18610571563 huangct@biohealthcare.com.cn

Locations
China, Beijing
Chinese Academy of Medical Sciences Tumor Hospital Recruiting
Beijing, Beijing, China
Contact: jinwan Wang       lyang69@sina.com   
Contact: lin Yang       lyang69@sina.com   
Principal Investigator: jinwan Wang         
Principal Investigator: lin Yang         
Sponsors and Collaborators
Beijing Biohealthcare Biotechnology Co.,Ltd
Investigators
Principal Investigator: jinwan Wang Chinese Academy of Medical Sciences Tumor Hospital
Principal Investigator: lin yang Chinese Academy of Medical Sciences Tumor Hospital

Responsible Party: Beijing Biohealthcare Biotechnology Co.,Ltd
ClinicalTrials.gov Identifier: NCT02504229     History of Changes
Other Study ID Numbers: GC-A-004
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

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