Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01906632

Enrollment

Registered

2013-07-24

Start date

2013-05-31

Completion date

2023-06-30

Last updated

2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumor

Brief summary

To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.

Detailed description

1. The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) . 2. Venous blood (4 ml) is collected from each subject and placed into tubes containing Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until processing. 3. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。 4. Estimate Immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. Response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy. 5. Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.

Interventions

BIOLOGICALDC-CIK Immunotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* histologically confirmed with malignant tumor; * Age: 18-80 years; * an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; * At least one measurable lesion according to the RECIST criteria; * Adequate bone marrow, cardiac, liver, and renal function; * Life expectancy ≥2 months; * Not received other anti-tumor treatment * Informed consent signed

Exclusion criteria

* previous history of other malignancies; * Uncontrolled central nervous system metastases; * Serious or uncontrolled concurrent medical illness.

Design outcomes

Primary

Measure	Time frame
T-Cell Receptor/B-Cell Receptor gene expression	3 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026