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

Phase 2

• Conditions: Colon Cancer
• Interventions: Drug: placebo; Drug: rhGM-CSF

• Registration Number: NCT02466906
• Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-05
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-09
• Status Verified: 2015-12
• Last Update Submitted: 2016-01-18
• Last Update Posted: 2016-01-20
• Primary Completion: 2020-06
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	Placebo was injected subcutaneously perioperation.
rhGM-CSF group	rhGM-CSF	rhGM-CSF was injected subcutaneously perioperation.

Primary Outcome Measures

Name	Time	Method
Disease-free survival（DFS）	5 years

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	5 years
Incidence of liver metastasis	5 years
Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells	5
Adverse effects (AE)	5 years

Trial Locations

Locations (1)

307 Hospital of PLA; 🇨🇳 Beijing, Beijing, China