Study of DC-CIK to Treat NPC

NCT ID: NCT01821495

Last Updated: 2013-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-05-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

B

After accepting concurrent radiotherapy and chemotherapy, patients will just regularly follow up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

A

After accepting concurrent radiotherapy and chemotherapy, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK)treatment.

Group Type: EXPERIMENTAL

DC-CIK

Intervention Type: BIOLOGICAL

Dendritic and Cytokine-induced Killer Cells

Intervention Type: BIOLOGICAL

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

Interventions

DC-CIK

Intervention Type: BIOLOGICAL

Dendritic and Cytokine-induced Killer Cells

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

Intervention Type: BIOLOGICAL

Other Intervention Names

DC-CIK

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Weiliang Sun

investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanfeng Liu

Role: STUDY_CHAIR

Guangxi Medical University

Locations

Guangxi Medical University

Nanning, Guangxi, China

Countries

China

Central Contacts

Weiliang Sun, M.D.

Role: CONTACT

swl20012002@sohu.com

86-771-3277289

Other Identifiers

NPC-01

Identifier Type: -

Identifier Source: org_study_id