Clinical trial · Interventional
Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer
Autologous Dendritic Cell-cytokine Induced Killer Cell Immunotherapy Combined With S-1 Based Chemotherapy in Patients With Advanced Gastric Cancer
NCT01783951CI-TRIAL-00033857completedPhase 1 / Phase 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)
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.
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 |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| DC-CIK | Biological | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DC-CIK plus S-1 based chemotherapy
- description
- Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone. Meanwhile those patients will receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.
- interventionNames
- Biological: DC-CIK
- Drug: S-1
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- S-1 based chemotherapy
- description
- Patients will be receive S-1 based chemotherapy, including S-1 plus cisplatin or S-1 alone.Cycles were repeated every 21 days. Treatment was continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.
- interventionNames
- Drug: S-1
- Drug: Cisplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.