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

NCT02466906 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-01-20

No results posted yet for this study

Summary

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

Conditions

Interventions

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).

Sponsors & Collaborators

  • The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

    lead OTHER

Principal Investigators

  • Xu jianming, M.D. · 307 Hospital of PLA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2020-06-30
Completion
2020-07-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02466906 on ClinicalTrials.gov