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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01821495
Other study ID # NPC-01
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received March 27, 2013
Last updated April 11, 2013
Start date May 2013
Est. completion date May 2018

Study information

Verified date April 2013
Source Guangxi Medical University
Contact Weiliang Sun, M.D.
Phone 86-771-3277289
Email swl20012002@sohu.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment failure. A series of studies reported that dendritic and cytokine-induced killer cells (DC-CIK) have a broad anti-tumor spectrum. We suppose that DC-CIK will improve the prognosis of NPC. In this study, the patients with NPC will be treated with DC-CIK cells after concurrent of chemotherapy and radiotherapy. The purpose of this study is to evaluate the efficacy of DC-CIK for NPC.


Description:

About 60 patients with staging Ⅱ-Ⅲ of NPC, after accepting concurrent radiotherapy and chemotherapy, will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patients with staging ?-? of NPC;

2. Patients who had completed concurrent of radiotherapy and chemotherapy;

3. Patients who have a life expectancy of at least 12 weeks;

4. Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;

5. The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);

6. The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

1. Patients who had distant metastases by imaging studies;

2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening;

3. Patients who were pregnant or lactating;

4. ECOG perform status = 2;

5. Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
DC-CIK

Dendritic and Cytokine-induced Killer Cells
Concurrent of radiotherapy and chemotherapy plus 3 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment

Locations

Country Name City State
China Guangxi Medical University Nanning Guangxi

Sponsors (1)

Lead Sponsor Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Laboratory findings 1 month No
Primary progression-free survival(PFS) 1 month No
Secondary overall survival(OS) 1 month No
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