Clinical trial · Interventional
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
NCT02504229CI-TRIAL-00018585unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous dendritic cells co-cultured with cytokine-induced killer cells | Biological | — | UNRESOLVED |
| Gimeracil and Oteracil Porassium Capsules | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy+DC-CIK
- 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.
- interventionNames
- Biological: autologous dendritic cells co-cultured with cytokine-induced killer cells
- Drug: Gimeracil and Oteracil Porassium Capsules
- Drug: Oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy alone
- 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.
- interventionNames
- Drug: Gimeracil and Oteracil Porassium Capsules
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMa X, Peng L, Wang J, Gao L, Zhang W, Lu X, Liu J, Yang L. Autologous CIK cells combined with chemotherapy as the first-line treatment for locally advanced or metastatic gastric cancer is safe and feasible. Front Immunol. 2023 Nov 1;14:1267369. doi: 10.3389/fimmu.2023.1267369. eCollection 2023. PMID 38022664