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A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Staging Ⅱ-Ⅲ of Nasopharyngeal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Nasopharyngeal Carcinoma

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Trial Information

A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Staging Ⅱ-Ⅲ of Nasopharyngeal Carcinoma


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.


Inclusion Criteria:



1. Patients with staging Ⅱ-Ⅲ 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

progression-free survival(PFS)

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Hanfeng Liu

Investigator Role:

Study Chair

Investigator Affiliation:

Guangxi Medical University

Authority:

China: Ministry of Health

Study ID:

NPC-01

NCT ID:

NCT01821495

Start Date:

May 2013

Completion Date:

May 2018

Related Keywords:

  • Nasopharyngeal Carcinoma
  • NPC,DC-CIK
  • Carcinoma
  • Nasopharyngeal Neoplasms

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