Brief Title
Study of DC-CIK to Treat NPC
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
progression-free survival(PFS)
Secondary Outcome
overall survival(OS)
Condition
Nasopharyngeal Carcinoma
Intervention
DC-CIK
Study Arms / Comparison Groups
B
Description: After accepting concurrent radiotherapy and chemotherapy, patients will just regularly follow up.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
100
Start Date
May 2013
Completion Date
May 2018
Primary Completion Date
May 2018
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Hanfeng Liu, 86-771-3277289, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01821495
Organization ID
NPC-01
Responsible Party
Principal Investigator
Study Sponsor
Guangxi Medical University
Study Sponsor
Hanfeng Liu, Study Chair, Guangxi Medical University
Verification Date
April 2013