Study of DC-CIK to Treat NPC

Guangxi Medical University

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Biological: Dendritic and Cytokine-induced Killer Cells; Biological: DC-CIK

Study type: Interventional

Funder types: Other

Identifiers

NCT01821495

NPC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

B

No Intervention group

Description:

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

A

Experimental group

Description:

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

Treatment:

Biological: Dendritic and Cytokine-induced Killer Cells

Biological: DC-CIK