Colon Cancer
Conditions
Keywords
Stage III colon cancer, rhGM-CSF, Immunotherapy, Surgery, Adjuvant chemotherapy
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.
Interventions
DRUGrhGM-CSF
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.
DRUGplacebo
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).
Sponsors
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed as resectable stage III colon cancer 2. 18-70 years old 3. ECOG performance status ≤2 4. Unexposed to rhGM-CSF in 6 months 5. Signed an informed consent document
Exclusion criteria
1. 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) 2. Complete intestinal obstruction 3. 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 4. 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% ) 5. Bone marrow dysfunction ( Hb\<9.0 g/dL、ANC\<1.5 x 109/L、PLT\<100 x 109/L ) 6. ITP or immunodeficiency 7. Uncontrolled infection, including HBV, HCV, HIV infection 8. Female patients who has been pregnant or planning to, and those during lactation 9. Known allergic to E.coli agents or rhGM-CSF or any severe allergic history to other drugs 10. Other cases that the researcher found ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival（DFS） | 5 years |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactXu jianming, M.D.
Outcome results
None listed