Gastric Cancer
Conditions
Brief summary
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.
Interventions
BIOLOGICALautologous dendritic cells co-cultured with cytokine-induced killer cells
DRUGGimeracil and Oteracil Porassium Capsules
DRUGOxaliplatin
Sponsors
Beijing Biohealthcare Biotechnology Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | 6 weeks |
Countries
China
Contacts
Primary ContactJingwei liu, PhD
Backup ContactTsai Ting Huang
Outcome results
None listed