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

Completed

• Conditions: Malignant Tumor

• Registration Number: NCT01884168
• Lead Sponsor: Capital Medical University

Brief Summary

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.

Detailed Description

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

2. 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.

3. The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.

4. 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.

5. Statistical analysis is performed using unsupervised hierarchical cluster.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-21
• Primary Completion: 2022-12
• Study Completion: 2023-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunotherapy response	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

Trial Locations

Locations (1)

Capital Medical University Cancer Center/Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China