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

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

Study Overview

• Status: Unknown
• Conditions: Colon Cancer
• Intervention / Treatment: Drug: rhGM-CSF; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100071
      • Recruiting
      • 307 Hospital of PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival（DFS）	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	5 years
Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells	5
Incidence of liver metastasis	5 years
Adverse effects (AE)	5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 18, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Surgery; Adjuvant chemotherapy; Immunotherapy; Stage III colon cancer; rhGM-CSF
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: L-15-01