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

Not Applicable

Completed

• Conditions: Malignant Tumor
• Interventions: Biological: DC-CIK Immunotherapy

• Registration Number: NCT01906632
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-21
• Study First Submitted QC: 2013-07-21
• Study First Posted: 2013-07-24
• Primary Completion: 2022-12-30
• Study Completion: 2023-06-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gene expression profile	DC-CIK Immunotherapy	-

Primary Outcome Measures

Name	Time	Method
T-Cell Receptor/B-Cell Receptor gene expression	3 month

Trial Locations

Locations (1)

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital; 🇨🇳 Beijing, China