Study of DC-CIK to Treat NPC

NCT01821495 | Unknown Phase 2 DMC

• 1 other identifier: NPC-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

NPC,DC-CIK

Outcome Measures

Primary Outcomes (1)

• progression-free survival(PFS)

  1 month

Secondary Outcomes (1)

• overall survival(OS)

  1 month

Other Outcomes (1)

• Laboratory findings

  1 month

Study Arms (2)

B

NO INTERVENTION

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

A

EXPERIMENTAL

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

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

Interventions

DC-CIK BIOLOGICAL

A

Dendritic and Cytokine-induced Killer Cells BIOLOGICAL

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

Also known as: DC-CIK

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Guangxi Medical University

Nanning, Guangxi, 530000, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Hanfeng Liu

  Guangxi Medical University

  STUDY CHAIR

Central Study Contacts

Weiliang Sun, M.D.

CONTACT

86-771-3277289; swl20012002@sohu.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 1, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

CN (1)