Study of DC-CIK to Treat Colorectal Cancer

April 22, 2013 updated by: Weiliang Sun, Guangxi Medical University

Phase Ⅱ Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Stage Ⅲ Colorectal Cancer

The purpose of this study is to evaluate the efficacy of dendritic and cytokine-induced killer cells (DC-CIK) for colorectal cancer (CRC).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

60 patients with stage Ⅲ CRC, who had received neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, and got complete response (CR), 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)

60

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
        • Recruiting
        • Guangxi Medical University
        • Contact:
          • Hanfeng Liu
          • Phone Number: 86-771-3277289
        • Principal Investigator:
          • Hanfeng Liu

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. Male or female patients ≥ 18 years of age;
  2. CRC with histological diagnose, and had received neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy and got complete response (CR) with imaging;
  3. Patients who have a life expectancy of at least 3 months;
  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
No Intervention: B
After neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, patients will only regularly follow up.
Experimental: A
After neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, patients will receive 2-3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK) treatment (every 4 weeks).
Biological: dendritic and cytokine-induced killer cells
Other Names:
  • DC-CIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: 5 years
5 years
Quality of life (QOL)
Time Frame: 5 years
5 years
Laboratory findings (The number of CD3+ (or CD8+ or CD4+ or CD56+)T cell)
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

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

March 1, 2013

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

April 14, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 22, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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