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

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Treatments: Molgramostim

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