RhGM-CSF as Adjuvant Immunotherapy in Treating Stage III Colon Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Recombinant Human Granulocyte-macrophage Colony-stimulating Factor as Adjuvant Immunotherapy in Treating Resectable Stage III Colon Cancer: A Randomized, Placebo-controlled Clinical Trial

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: rhGM-CSF
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhGM-CSF group<br>rhGM-CSF was injected subcutaneously perioperation. | Drug: rhGM-CSF<br>* 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.<br>|
| Placebo Comparator: placebo group<br>Placebo was injected subcutaneously perioperation. | Drug: placebo<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival（DFS） |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells |  | 5 | 
| Overall survival (OS) |  | 5 years | 
| Incidence of liver metastasis |  | 5 years | 
| Adverse effects (AE) |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage III colon cancer, rhGM-CSF, Immunotherapy, Surgery, Adjuvant chemotherapy