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

Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884168
• Other study ID #: GIMCEI
• Status: Completed
• Start date: March 2013
• Est. completion date: May 2023

Study information

• Verified date: February 2024
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

Biological:
• Dc-CIK immunotherapy
The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.

Locations

Country	Name	City	State
China	Capital Medical University Cancer Center/Beijing Shijitan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunotherapy response	T-Cell Receptor and B-Cell Receptor gene expression profiling and the change of cytokines, lymphocytes subpopulation before and after DC-CIK infusion	1 month