Back to resultsDC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fluorouracil
Oxaliplatin
Leucovorin
DC-CIK
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Stage III colon cancer
- Undergone complete resection of primary tumor
- Completed standard adjuvant chemotherapy
- ECOG performancer status 0-2
- Adequate hematologic, hepatic and renal functions
Exclusion Criteria:
- HIV positive or other Immunodeficiency disease
- Uncontrolled hypertension
- History of recent cancers in the past 5 years
- Patients with previous or concurrent malignancy or any anti-cancer therapy
- Patients who were allergic to platinum drugs or fluorouracil
- Pregnant patients
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DC-CIK Immunotherapy Plus Chemotherapy
Chemotherapy Alone
Arm Description
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
Outcomes
Primary Outcome Measures
Disease free survival
Secondary Outcome Measures
Overall survival
Side Effect
Full Information
NCT ID
NCT02415699
First Posted
April 9, 2015
Last Updated
April 13, 2015
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02415699
Brief Title
DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer
Official Title
Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
4. Oversight
5. Study Description
Brief Summary
Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DC-CIK Immunotherapy Plus Chemotherapy
Arm Type
Experimental
Arm Description
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
Arm Title
Chemotherapy Alone
Arm Type
Active Comparator
Arm Description
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5-FU
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Type
Biological
Intervention Name(s)
DC-CIK
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
Title
Side Effect
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage III colon cancer
Undergone complete resection of primary tumor
Completed standard adjuvant chemotherapy
ECOG performancer status 0-2
Adequate hematologic, hepatic and renal functions
Exclusion Criteria:
HIV positive or other Immunodeficiency disease
Uncontrolled hypertension
History of recent cancers in the past 5 years
Patients with previous or concurrent malignancy or any anti-cancer therapy
Patients who were allergic to platinum drugs or fluorouracil
Pregnant patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojian Wu, MD, PHD
Phone
020-38254009
Email
sumswxj@126.com
12. IPD Sharing Statement
Learn more about this trial
DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer
We'll reach out to this number within 24 hrs