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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-07-31

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.

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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.

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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rhGM-CSF group

rhGM-CSF was injected subcutaneously perioperation.

Group Type EXPERIMENTAL

rhGM-CSF

Intervention Type DRUG

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 group

Placebo was injected subcutaneously perioperation.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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).

Interventions

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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.

Intervention Type 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).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No