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

Malignant Tumor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906632
• Other study ID #: GIMC
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

Biological:
• DC-CIK Immunotherapy

Locations

Country	Name	City	State
China	Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T-Cell Receptor/B-Cell Receptor gene expression		3 month