Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy

NCT ID: NCT01906632

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2023-06-30

Brief Summary

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

Detailed Description

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1. The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) .
2. 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.
3. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。
4. 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.
5. Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.

Conditions

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Malignant Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gene expression profile

Group Type OTHER

DC-CIK Immunotherapy

Intervention Type BIOLOGICAL

Interventions

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DC-CIK Immunotherapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jun Ren MD, PhD

Director, Capita Medical University Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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GIMC

Identifier Type: -

Identifier Source: org_study_id

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