Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy | NCT01906632 | Trialant
CompletedInterventionalNot ApplicableUpdated Feb 7, 2024
Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy
ClinicalTrials.gov ID
NCT01906632
Lead Sponsor
Capital Medical UniversityOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
50Actual
Last Update Posted
Feb 7, 2024Actual
Start Date
May 2013Actual
Primary Completion Date
Dec 30, 2022Actual
Completion Date
Jun 30, 2023Actual
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
The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) .
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.
The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。
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.
Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.
Malignant Tumor
DC-CIK Immunotherapy
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Primary Purpose
Treatment
Allocation
N/A
Interventional Model
Single Group Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital