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A single-center, randomized, clinical study of the clinical application value of a single dose of peg-rhG-CSF and daily rhG-CSF in advanced gastric cancer neoadjuvant chemotherapy FLOT

A single-center, randomized, clinical study of the clinical application value of a single dose of peg-rhG-CSF and daily rhG-CSF in advanced gastric cancer neoadjuvant chemotherapy FLOT

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17012923
Enrollment
Unknown
Registered
2017-10-10
Start date
2017-12-01
Completion date
Unknown
Last updated
2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced gastrc cancer

Interventions

Group 2:rh-CSF

Sponsors

Liaoning Cancer Hospital and Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. All patients gave written informed consent before any study-related procedure was performed; 2. Pathological or cytological diagnosis is gastric cancer and included patients satisfied the chemotherapy-related essential requirements; 3. Adequate heart,renal,hepatic and cardiac function and non-pregnant or no mental illness; 4. KPS score ranged from 70 to 100; 5. Incidence rate of FN =20%; 6. Primary chemotherapy and TNM stage is IIIa-IIIc (staging by CT, endoscopy, MRI, PET-CT); 7. No metachysis and no applying neutropenia treatment-related drugs such as DMPA,MA,ACTH,no radiation and chemotherapy; 8. WBC>4.0×10^9/L, PMN>2.0×10^9/L, PLT>100×10^9/L before chemotherapy.

Exclusion criteria

Exclusion criteria: 1. Patients are allergic to G-CSF and PEG-rhG-CSF; 2. Patient compliances are bad or refusing to apply G-CSF and PEG-rhG-CSF; 3. If patients had worse bone marrow suppression or infection and needed to other updating WBC; 4. Patients happened untolerable and/or worse reactions even to be life-threatening when using G-CSF and PEG-rhG-CSF; 5. Blood routine was abnormal before chemotherapy; 6. Patients had related-cardiac disease and hepatic and renal function were inadequate; 7. Metachysis and applying neutropenia treatment-related drugs.

Design outcomes

Primary

MeasureTime frame
Neutrophil descent time;

Secondary

MeasureTime frame
Chemotherapy-related delay rate;Chemotherapy-related completion rate;mean hospitalization cost;Perioperative infection rate;

Countries

China

Contacts

Public ContactZhao Yan

Liaoning Cancer Hospital and Institute

dr.zhaoyan@126.com+86 18900918909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026