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NCT Number: NCT01884168

Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy

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

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Key information

Conditions

Malignant Tumor Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Capital Medical University Cancer Center/Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

About this study

  • The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
  • Malignant cavity effusion from cancer patients is obtained through puncture and is centrifugalized to get supernatant fluid and enrich cancer cells before and after the therapy.
  • The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.
  • The T-Cell Receptor/B-Cell Receptor gene expression in cavity effusion is detected by micro-array to explore the mechanism that DC-CIK immunotherapy controls the malignant cavity effusion.
  • Statistical analysis is performed using unsupervised hierarchical cluster.

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 and malignant cavity effusion.
  • An Eastern Cooperative Oncology Group（ECOG）performance status of 0-2.
  • Normal cardiac, hepatic, renal and bone marrow functions.
  • Life expectancy >3 months.
  • Not receive other anti-tumor treatment.
  • Not receive chemotherapy in pleural and abdominal cavity.

Exclusion criteria

  • Previous history of other malignancies.
  • Serious or uncontrolled concurrent medical illness.

Treatment and study plan

DC-CIK Immunotherapy

Biological

The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.

Primary outcomes

  1. Immunotherapy response

    Time frame: 1 month

    T-Cell Receptor and B-Cell Receptor gene expression profiling and the change of cytokines, lymphocytes subpopulation before and after DC-CIK infusion

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Gene Expression Profiling and Immunological Mechanism Affects the Response of Malignant Cavity Effusion Towards DC-CIK Immunotherapy

Important dates

Study start
2013
Primary completion
2022
Study completion
2023
First posted
Jun 21, 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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