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

Beijing Biohealthcare Biotechnology

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Biological: autologous dendritic cells co-cultured with cytokine-induced killer cells; Drug: Gimeracil and Oteracil Porassium Capsules; Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02504229

GC-A-004

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Chemotherapy+DC-CIK

Experimental group

Description:

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.

Treatment:

Drug: Gimeracil and Oteracil Porassium Capsules

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

Drug: Oxaliplatin

Chemotherapy alone

Active Comparator group

Description:

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.

Treatment:

Drug: Gimeracil and Oteracil Porassium Capsules

Drug: Oxaliplatin