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
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: rhGM-CSF Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
Experimental: rhGM-CSF group
rhGM-CSF was injected subcutaneously perioperation.
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.
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).
- Disease-free survival（DFS） [ Time Frame: 5 years ]
- Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells [ Time Frame: 5 ]
- Overall survival (OS) [ Time Frame: 5 years ]
- Incidence of liver metastasis [ Time Frame: 5 years ]
- Adverse effects (AE) [ Time Frame: 5 years ]
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
|Contact: Xu jianming, M.D.||+firstname.lastname@example.org|
|307 Hospital of PLA||Recruiting|
|Beijing, Beijing, China, 100071|
|Contact: Xu jianming, M.D. +861051128358 email@example.com|
|Principal Investigator: Xu jianming, M.D.|
|Principal Investigator:||Xu jianming, M.D.||307 Hospital of PLA|