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

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

Study Overview

• Status: Completed
• Conditions: Malignant Tumor
• Intervention / Treatment: Biological: 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100038
    • Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: gene expression profile	Biological: DC-CIK Immunotherapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 21, 2013
• First Submitted That Met QC Criteria: July 21, 2013
• First Posted (Estimated): July 24, 2013

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: GIMC