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Study of DC-CIK to Treat Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
dendritic and cytokine-induced killer cells
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, DC-CIK, CRC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangxi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

B

A

Arm Description

After neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, patients will only regularly follow up.

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).

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Overall survival (OS)
Quality of life (QOL)
Laboratory findings (The number of CD3+ (or CD8+ or CD4+ or CD56+)T cell)

Full Information

First Posted
April 14, 2013
Last Updated
April 22, 2013
Sponsor
Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01839539
Brief Title
Study of DC-CIK to Treat Colorectal Cancer
Official Title
Phase Ⅱ Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Stage Ⅲ Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, DC-CIK, CRC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
No Intervention
Arm Description
After neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy according to NCCN guidelines, patients will only regularly follow up.
Arm Title
A
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
dendritic and cytokine-induced killer cells
Other Intervention Name(s)
DC-CIK
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
5 years
Title
Quality of life (QOL)
Time Frame
5 years
Title
Laboratory findings (The number of CD3+ (or CD8+ or CD4+ or CD56+)T cell)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients ≥ 18 years of age; CRC with histological diagnose, and had received neoadjuvant and (or) adjuvant chemotherapy or (and) radiotherapy and got complete response (CR) with imaging; Patients who have a life expectancy of at least 3 months; 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. Exclusion Criteria: Patients who had distant metastases; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanfeng Liu
Phone
86-771-3277289
Facility Information:
Facility Name
Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanfeng Liu
Phone
86-771-3277289
First Name & Middle Initial & Last Name & Degree
Hanfeng Liu

12. IPD Sharing Statement

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Study of DC-CIK to Treat Colorectal Cancer

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