Trial | NCT02504229  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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.
Study Started
Nov 30
2014
Primary Completion
Jul 31
2018
Anticipated
Last Update
Jul 21
2015
Estimate

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

Drug Gimeracil and Oteracil Porassium Capsules

Drug Oxaliplatin

  • Other names: Eloxatin

Chemotherapy+DC-CIK Experimental

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.

Chemotherapy alone Active Comparator

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.

Criteria 

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.
No Results Posted