Study of DC-CIK to Treat NPC

April 11, 2013 updated by: Weiliang Sun, Guangxi Medical University

A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Staging Ⅱ-Ⅲ of Nasopharyngeal Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Guangxi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: B
After accepting concurrent radiotherapy and chemotherapy, patients will just regularly follow up.
Experimental: A
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
Concurrent of radiotherapy and chemotherapy plus 3 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment
Other Names:
  • DC-CIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival(PFS)
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival(OS)
Time Frame: 1 month
1 month

Other Outcome Measures

Outcome Measure
Time Frame
Laboratory findings
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Investigators

  • Study Chair: Hanfeng Liu, Guangxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

March 29, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Estimate)

April 12, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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