Clinical trial · Interventional
Maintenance Therapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer
Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer
- 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 role of maintenance therapy in the management of Small Cell Lung Cancer (SCLC) has not been confirmed. Many treatment modalities like chemotherapy, interferons and other biological agents have been tested as maintenance therapy in SCLC, but the results are disappointing. A marginal survival advantage is seen in maintenance with chemotherapy and interferon-alpha, however, the functioning status and immune system may get worse, which subsequently has a negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. This effect may result in improved tumor control and survival, as well as a better quality of life. To test the hypothesis, a randomized controlled study was conducted to compare CIK cells with best supportive care as maintenance therapy for SCLC.
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 |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous cytokine-induced killer cell | Biological | — | UNRESOLVED |
| Best Supportive Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immunotherapy
- description
- Subjects receive autologous cytokine-induced killer cell infusion every month
- interventionNames
- Biological: Autologous cytokine-induced killer cell
- type
- ACTIVE_COMPARATOR
- label
- Best Supportive Care
- description
- Best Supportive Care
- interventionNames
- Other: Best Supportive Care
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- One year
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven small cell lung cancer * Patients currently receiving 4-6 cycles of chemotherapy regimen with VP-16 and a platinum-based drug as first-line therapy in the absence of disease progression * Age between 18-75 * Performance status ≤2 * No uncontrolled metabolic disease, infection, and neurological disorders * No congestive heart failure, severe arrhythmia, and coronal atherosclerosis heart disease * Life expectancy more than three months. * Without contraindication of immunotherapy with autologous cytokine-induced killer cells * No other malignancies * Signed study-specific consent form prior to study entry Exclusion Criteria: * Patients receiving other anti-tumor therapy (like thermotherapy) * Pregnant or lactating women * Allergy or unacceptable toxicity of immunotherapy with autologous cytokine-induced killer cells * Uncontrolled mental disorder * Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
References
Publications (0)
Data not yet available