Nasopharyngeal Carcinoma
Conditions
Keywords
NPC,DC-CIK
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.
Interventions
BIOLOGICALDC-CIK
Concurrent of radiotherapy and chemotherapy plus 3 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment
Sponsors
Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS) | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| overall survival(OS) | 1 month |
Other
| Measure | Time frame |
|---|---|
| Laboratory findings | 1 month |
Countries
China
Contacts
Primary ContactWeiliang Sun, M.D.
Outcome results
None listed