Gastric Cancer
Conditions
Keywords
Gastric cancer, S-1, DC-CIK, T cell
Brief summary
The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness dendritic cell activated Cytokine induced killer treatment (DC-CIK) plus S-1 based chemotherapy for advanced gastric cancer.
Interventions
BIOLOGICALDC-CIK
Patients will be receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.
DRUGS-1
The dose of S-1 is determined according to the body surface area as follows: \<1.25 m2, 40 mg; 1.25 to \<1.5 m2, 50 mg; and ≥1.5 m2, 60 mg, given twice daily after meals for 14 days followed by 7 days rest.
DRUGCisplatin
Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.
Sponsors
Duke University
Geneplus-Beijing Co. Ltd.
Capital Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically/cytologically confirmed recurrent or metastatic gastric or esophagogastric junctional adenocarcinoma * Between 18 and 80 years old * Capable of oral intake * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Karnofsky Performance Status (KPS) ≥ 70% * Normal functions of heart, lung and bone marrow * Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3 * Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN * Adequate renal function(normal serum creatinine level) * A life expectancy≥ 2 months * Informed consent signed
Exclusion criteria
* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study * Any radiotherapy or surgery within the previous 4 weeks * Symptomatic brain metastasis not controlled by corticosteroids * Bone marrow metastasis * Active infection * Serious complications * Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid. * Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy * Ineligible for the study at the discretion of investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival（PFS） | 4 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 4 years | — |
| Response rate | Every 6 weeks | — |
| Adverse Events | Every 3 weeks | — |
| Quality of life | 6 weeks | Evaluation of quality of life will be performed every 2 cycles (6 weeks) from baseline to the end of treatment. |
Countries
China
Outcome results
None listed