Study of DC-CIK to Treat NPC

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Biological: DC-CIK
* Biological: Dendritic and Cytokine-induced Killer Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with staging Ⅱ-Ⅲ of NPC; Patients who had completed concurrent of radiotherapy and chemotherapy; Patients who have a life expectancy of at least 12 weeks; Eastern Cooperative Oncology Group (ECOG) performance status was 0-1; The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L); The ECG results were normal, and the liver and kidney were functional. Exclusion Criteria: Patients who had distant metastases by imaging studies; Patients with uncontrolled infection; underlying disease that was severe or life-threatening; Patients who were pregnant or lactating; ECOG perform status ≥ 2; Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: B<br>After accepting concurrent radiotherapy and chemotherapy, patients will just regularly follow up. | |
| Experimental: A<br>After accepting concurrent radiotherapy and chemotherapy, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK)treatment. | Biological: DC-CIK<br> <br> Biological: Dendritic and Cytokine-induced Killer Cells<br>* Concurrent of radiotherapy and chemotherapy plus 3 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment<br>* Other names: DC-CIK;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival(PFS) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival(OS) |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NPC,DC-CIK