NCT02466906

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 20, 2016

Status Verified

December 1, 2015

Enrollment Period

5 years

First QC Date

June 5, 2015

Last Update Submit

January 18, 2016

Conditions

Colon Cancer

Keywords

Stage III colon cancerrhGM-CSFImmunotherapySurgeryAdjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival（DFS）

    5 years

Secondary Outcomes (4)

  • Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells

    5

  • Overall survival (OS)

    5 years

  • Incidence of liver metastasis

    5 years

  • Adverse effects (AE)

    5 years

Study Arms (2)

rhGM-CSF group

EXPERIMENTAL

rhGM-CSF was injected subcutaneously perioperation.

Drug: rhGM-CSF

placebo group

PLACEBO COMPARATOR

Placebo was injected subcutaneously perioperation.

Drug: placebo

Interventions

rhGM-CSFDRUG

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.

rhGM-CSF group
placeboDRUG

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).

placebo group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as resectable stage III colon cancer
  • years old
  • ECOG performance status ≤2
  • Unexposed to rhGM-CSF in 6 months
  • Signed an informed consent document

You may not qualify if:

  • 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)
  • Complete intestinal obstruction
  • 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
  • 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% )
  • Bone marrow dysfunction ( Hb\<9.0 g/dL、ANC\<1.5 x 109/L、PLT\<100 x 109/L )
  • ITP or immunodeficiency
  • Uncontrolled infection, including HBV, HCV, HIV infection
  • Female patients who has been pregnant or planning to, and those during lactation
  • Known allergic to E.coli agents or rhGM-CSF or any severe allergic history to other drugs
  • Other cases that the researcher found ineligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

regramostim

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Xu jianming, M.D.

    307 Hospital of PLA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu jianming, M.D.

CONTACT

+861051128358jmxu2003@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 9, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

January 20, 2016

Record last verified: 2015-12

Locations

CN(1)