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

Study Overview
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Brief Summary
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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.

Conditions
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Gastric Cancer

Intervention / Treatment
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* Biological: autologous dendritic cells co-cultured with cytokine-induced killer cells
* Drug: Gimeracil and Oteracil Porassium Capsules
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>18y; ECOG physical status 0-1; The histologic diagnosis of stomach/gastroesophageal junction adenocarcinoma; According to the RECIST 1.1 standard with measurable or evaluable lesion; Accept swallow oral drug; 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; The expected survival time of more than 3 months; good compliance; Provide written informed consent. Exclusion Criteria: Vital organs (heart,liver,kidney) function is serious dysfunction; Patients received organ transplantation; Patients with other malignant tumors or have occurred brain metastasis; Patients with history of autoimmune disease; Patients in pregnancy or breast-feeding period(women of child-bearing age need to check pregnancy test); Patients with acute infection disease or in chronic active stage; Patients with clear history of drug allergy or belong to allergic constitution; Patients received chemotherapy,radiation therapy, immunosuppressive drugs (cyclosporine A,etc.) or other immune treatment in 4 weeks; Patients received other clinical trials in 4 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy+DC-CIK<br>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<br> <br> Drug: Gimeracil and Oteracil Porassium Capsules<br> <br> Drug: Oxaliplatin<br> <br> * Other names: Eloxatin;|
| Active Comparator: Chemotherapy alone<br>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<br> <br> Drug: Oxaliplatin<br> <br> * Other names: Eloxatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 6 weeks |