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

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ClinicalTrials.gov Identifier: NCT02466906
Recruitment Status : Recruiting
First Posted : June 9, 2015
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: rhGM-CSF Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: rhGM-CSF group
rhGM-CSF was injected subcutaneously perioperation.
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 Comparator: placebo group
Placebo was injected subcutaneously perioperation.
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).




Primary Outcome Measures :
  1. Disease-free survival(DFS) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells [ Time Frame: 5 ]
  2. Overall survival (OS) [ Time Frame: 5 years ]
  3. Incidence of liver metastasis [ Time Frame: 5 years ]
  4. Adverse effects (AE) [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466906


Contacts
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Contact: Xu jianming, M.D. +861051128358 jmxu2003@yahoo.com

Locations
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China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China, 100071
Contact: Xu jianming, M.D.    +861051128358    jmxu2003@yahoo.com   
Principal Investigator: Xu jianming, M.D.         
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
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Principal Investigator: Xu jianming, M.D. 307 Hospital of PLA

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Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02466906     History of Changes
Other Study ID Numbers: L-15-01
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: December 2015

Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Stage III colon cancer
rhGM-CSF
Immunotherapy
Surgery
Adjuvant chemotherapy

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Molgramostim
Sargramostim
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents