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

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Colon Cancer

Treatments: Drug: placebo; Drug: rhGM-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT02466906

L-15-01

Details and patient eligibility

About

This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

rhGM-CSF group

Experimental group

Description:

rhGM-CSF was injected subcutaneously perioperation.

Treatment:

Drug: rhGM-CSF

placebo group

Placebo Comparator group

Description:

Placebo was injected subcutaneously perioperation.

Treatment:

Drug: placebo