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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

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.

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Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

autologous dendritic cells co-cultured with cytokine-induced killer cells

Intervention Type BIOLOGICAL

Gimeracil and Oteracil Porassium Capsules

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Gimeracil and Oteracil Porassium Capsules

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Interventions

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autologous dendritic cells co-cultured with cytokine-induced killer cells

Intervention Type BIOLOGICAL

Gimeracil and Oteracil Porassium Capsules

Intervention Type DRUG

Oxaliplatin

Intervention Type DRUG

Other Intervention Names

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Eloxatin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No