RhGM-CSF as Adjuvant Immunotherapy in Treating Stage III Colon Cancer
January 18, 2016 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Recombinant Human Granulocyte-macrophage Colony-stimulating Factor as Adjuvant Immunotherapy in Treating Resectable Stage III Colon Cancer: A Randomized, Placebo-controlled Clinical Trial
This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers.
Study Overview
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.
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
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Beijing
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Beijing, Beijing, China, 100071
- Recruiting
- 307 Hospital of PLA
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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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: rhGM-CSF group
rhGM-CSF was injected subcutaneously perioperation.
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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.
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Placebo Comparator: placebo group
Placebo was injected subcutaneously perioperation.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Disease-free survival（DFS）
Time Frame: 5 years
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5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Overall survival (OS)
Time Frame: 5 years
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5 years
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Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells
Time Frame: 5
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5
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Incidence of liver metastasis
Time Frame: 5 years
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5 years
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Adverse effects (AE)
Time Frame: 5 years
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
June 1, 2015
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
July 1, 2020
Study Registration Dates
First Submitted
June 5, 2015
First Submitted That Met QC Criteria
June 8, 2015
First Posted (Estimate)
June 9, 2015
Study Record Updates
Last Update Posted (Estimate)
January 20, 2016
Last Update Submitted That Met QC Criteria
January 18, 2016
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L-15-01
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.