Back to resultsRhGM-CSF as Adjuvant Immunotherapy in Treating Stage III Colon Cancer
Primary Purpose
Colon Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
rhGM-CSF
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring Stage III colon cancer, rhGM-CSF, Immunotherapy, Surgery, Adjuvant chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosed as resectable stage III colon cancer
- 18-70 years old
- ECOG performance status ≤2
- Unexposed to rhGM-CSF in 6 months
- Signed an informed consent document
Exclusion Criteria:
- Secondary primary cancer, or concurrent primary malignancies (except for basal cell or squamous cell skin cancer, cervical cancer in situ, and other cancer with disease free for more than 5 years)
- Complete intestinal obstruction
- Events within 6 months before randomization: myocardial infarction, sever or unstable angina, coronary artery or peripheral arterial bypass surgery, congestive heart failure ( NYHA functional class of III or IV ), stroke and any myocardial dysfunction in a transient ischaemic attack
- Abnormal liver and kidney function (Serum creatinine > 1.5 x ULN, total bilirubin > 1.5 x ULN, transaminase > 3 x ULN ), abnormal pulmonary function (FEV1<60% or diffusing capacity of the lung for carbon monoxide < 55% )
- Bone marrow dysfunction ( Hb<9.0 g/dL、ANC<1.5 x 109/L、PLT<100 x 109/L )
- ITP or immunodeficiency
- Uncontrolled infection, including HBV, HCV, HIV infection
- Female patients who has been pregnant or planning to, and those during lactation
- Known allergic to E.coli agents or rhGM-CSF or any severe allergic history to other drugs
- Other cases that the researcher found ineligible
Sites / Locations
- 307 Hospital of PLARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
rhGM-CSF group
placebo group
Arm Description
rhGM-CSF was injected subcutaneously perioperation.
Placebo was injected subcutaneously perioperation.
Outcomes
Primary Outcome Measures
Disease-free survival（DFS）
Secondary Outcome Measures
Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells
Overall survival (OS)
Incidence of liver metastasis
Adverse effects (AE)
Full Information
NCT ID
NCT02466906
First Posted
June 5, 2015
Last Updated
January 18, 2016
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02466906
Brief Title
RhGM-CSF as Adjuvant Immunotherapy in Treating Stage III Colon Cancer
Official Title
Recombinant Human Granulocyte-macrophage Colony-stimulating Factor as Adjuvant Immunotherapy in Treating Resectable Stage III Colon Cancer: A Randomized, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers.
Detailed Description
This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers. Patients were randomly assigned to rhGM-CSF group or placebo group and treated with rhGM-CSF or placebo perioperation and during the adjuvant chemotherapy. The purpose of the study is to evaluate the antitumor immune effect of rhGM-CSF before surgery and adjuvant chemotherapy through DFS of 5 years and to observe the safety during the treatment in order to provide evidence for improvement in treating resectable colon cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Stage III colon cancer, rhGM-CSF, Immunotherapy, Surgery, Adjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rhGM-CSF group
Arm Type
Experimental
Arm Description
rhGM-CSF was injected subcutaneously perioperation.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo was injected subcutaneously perioperation.
Intervention Type
Drug
Intervention Name(s)
rhGM-CSF
Intervention Description
rhGM-CSF was injected subcutaneously of 3± 0.3ug/kg/d per day for 5 days before and 2 days after surgery. During adjuvant therapy of XELOX, rhGM-CSF was continuous injected for 6 days when finishing each cycle of chemotherapy (from d15) or stopped when ANC>20.0X109/L.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo was injected subcutaneously of 3± 0.3ug/kg/d per day for 5 days before and 2 days after surgery. . During adjuvant therapy of XELOX, placebo was continuous injected for 6 days when finishing each cycle of chemotherapy (from d15).
Primary Outcome Measure Information:
Title
Disease-free survival（DFS）
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells
Time Frame
5
Title
Overall survival (OS)
Time Frame
5 years
Title
Incidence of liver metastasis
Time Frame
5 years
Title
Adverse effects (AE)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed as resectable stage III colon cancer
18-70 years old
ECOG performance status ≤2
Unexposed to rhGM-CSF in 6 months
Signed an informed consent document
Exclusion Criteria:
Secondary primary cancer, or concurrent primary malignancies (except for basal cell or squamous cell skin cancer, cervical cancer in situ, and other cancer with disease free for more than 5 years)
Complete intestinal obstruction
Events within 6 months before randomization: myocardial infarction, sever or unstable angina, coronary artery or peripheral arterial bypass surgery, congestive heart failure ( NYHA functional class of III or IV ), stroke and any myocardial dysfunction in a transient ischaemic attack
Abnormal liver and kidney function (Serum creatinine > 1.5 x ULN, total bilirubin > 1.5 x ULN, transaminase > 3 x ULN ), abnormal pulmonary function (FEV1<60% or diffusing capacity of the lung for carbon monoxide < 55% )
Bone marrow dysfunction ( Hb<9.0 g/dL、ANC<1.5 x 109/L、PLT<100 x 109/L )
ITP or immunodeficiency
Uncontrolled infection, including HBV, HCV, HIV infection
Female patients who has been pregnant or planning to, and those during lactation
Known allergic to E.coli agents or rhGM-CSF or any severe allergic history to other drugs
Other cases that the researcher found ineligible
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu jianming, M.D.
Phone
+861051128358
Email
jmxu2003@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu jianming, M.D.
Organizational Affiliation
307 Hospital of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
307 Hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu jianming, M.D.
Phone
+861051128358
Email
jmxu2003@yahoo.com
First Name & Middle Initial & Last Name & Degree
Xu jianming, M.D.
12. IPD Sharing Statement
Learn more about this trial
RhGM-CSF as Adjuvant Immunotherapy in Treating Stage III Colon Cancer
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