A Study of DC-CIK to Treat Hepatocellular Carcinoma

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 Hepatocellular Carcinoma

The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

About 60 patients with HCC, who had received complete resection or TACE and got Complete remission (CR) or partial response (PR), 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
        • The First Affiliated Hospital of 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female patients > 18 years of age;
  2. Hepatocellular carcinoma with histological or imaging and AFP diagnose, and had received complete resection or TACE and got CR or PR by imaging studies;
  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;
  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
Experimental: A
After complete resection or TACE, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK) (every 4 weeks)
Biological: Dendritic and Cytokine-induced Killer Cells
Other Names:
  • DC-CIK
No Intervention: B
After complete resection or TACE, Patient only regularly follow up

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
quality of life (QOL)
Time Frame: month
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

  • HCC-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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