NCT02466906

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

Recombinant Human Granulocyte-macrophage Colony-stimulating Factor as Adjuvant Immunotherapy in Treating Resectable Stage III Colon Cancer: A Randomized, Placebo-controlled Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
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.
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).

Timeline

• Start date: 2015-06-01
• Primary completion: 2020-06-01
• Completion: 2020-07-01
• First posted: 2015-06-09
• Last updated: 2016-01-20

Locations

1 site across 1 country: China