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

Capital Medical University

Status: Completed

Conditions: Malignant Tumor

Treatments: Biological: DC-CIK Immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01906632

GIMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

gene expression profile

Other group

Treatment:

Biological: DC-CIK Immunotherapy