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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02466906
• Other study ID #: L-15-01
• Status: Recruiting
• Phase: Phase 2
• First received: June 5, 2015
• Last updated: January 18, 2016
• Start date: June 2015
• Est. completion date: July 2020

Study information

• Verified date: December 2015
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: Xu jianming, M.D.
• Phone: +861051128358
• Email: jmxu2003[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer

Intervention

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
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).

Locations

Country	Name	City	State
China	307 Hospital of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival(DFS)		5 years	No
Secondary	Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells		5	No
Secondary	Overall survival (OS)		5 years	No
Secondary	Incidence of liver metastasis		5 years	No
Secondary	Adverse effects (AE)		5 years	Yes