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

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02466906

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Drug: rhGM-CSF Drug: placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rhGM-CSF group rhGM-CSF was injected subcutaneously perioperation.	Drug: rhGM-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.
Placebo Comparator: placebo group Placebo was injected subcutaneously perioperation.	Drug: placebo 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).

Arm

Intervention/Treatment

Experimental: rhGM-CSF group

rhGM-CSF was injected subcutaneously perioperation.

Drug: rhGM-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.

Placebo Comparator: placebo group

Placebo was injected subcutaneously perioperation.

Drug: placebo

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).

Outcome Measures

Primary Outcome Measures

Disease-free survival（DFS） [5 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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