Clinical trial NCT02466906: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colon Cancer
Keywords: Stage III colon cancer
rhGM-CSF
Immunotherapy
Surgery
Adjuvant chemotherapy
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival（DFS）
timeFrame: 5 years
Secondary outcomes:
measure: Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells
timeFrame: 5
measure: Overall survival (OS)
timeFrame: 5 years
measure: Incidence of liver metastasis
timeFrame: 5 years
measure: Adverse effects (AE)
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 Hospital of PLA
state: Beijing
Study officials:
affiliation: 307 Hospital of PLA
name: Xu jianming, M.D.
role: PRINCIPAL_INVESTIGATOR
References: