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Completed

NCT Number: NCT01906632

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Beijing, 100038, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DC-CIK Immunotherapy

Biological

Primary outcomes

  1. T-Cell Receptor/B-Cell Receptor gene expression

    Time frame: 3 month

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Important dates

Study start
2013
Primary completion
2022
Study completion
2023
First posted
Jul 24, 2013
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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