Clinical trial · Interventional
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
NCT02466906CI-TRIAL-00020595unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| rhGM-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- rhGM-CSF group
- description
- rhGM-CSF was injected subcutaneously perioperation.
- interventionNames
- Drug: rhGM-CSF
- type
- PLACEBO_COMPARATOR
- label
- placebo group
- description
- Placebo was injected subcutaneously perioperation.
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Disease-free survival（DFS）
- timeFrame
- 5 years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.