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Study on the Safety and Efficacy of PEG-rhG-CSF Prevention versus PEG-rhG-CSF Treatment and rhG-CSF Treatment for Neutropenia Associated with Concurrent Weekly Chemotherapy in Cervical Cancer Radiotherapy

Study on the Safety and Efficacy of PEG-rhG-CSF Prevention versus PEG-rhG-CSF Treatment and rhG-CSF Treatment for Neutropenia Associated with Concurrent Weekly Chemotherapy in Cervical Cancer Radiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127260
Enrollment
Unknown
Registered
2026-06-28
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Cervical cancer

Interventions

Group of PEG-rhG-CSF Prevention:Prophylactic use of PEG-rhG-CSF
group of PEG-rhG-CSF treatment:Therapeutic application of PEG-rhG-CSF (Xinruibai)
group of rhG-CSF treatment:Granulocyte Colony-Stimulating Factor Injection

Sponsors

HenanCancerHospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with cervical cancer confirmed by histopathology; 2. Age >= 18 years, =1.5×10^9/L, platelet count (PLT) >=80×10^9/L, hemoglobin (Hb) >=75 g/L, white blood cell count (WBC) >=3×10^9/L, and no bleeding tendency; 7. No signs of bone metastasis were detected before treatment; 8. The subjects voluntarily participated in this clinical trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Have undergone hematopoietic stem cell transplantation or bone marrow transplantation; 2.During the current treatment course, PEG-rhG-CSF or rhG-CSF is used to prevent ANC reduction; 3.Currently participating in other drug clinical trials; 4.Currently has an uncontrollable infection, or has received systemic antibiotic treatment within 72 hours before chemotherapy; 5.Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are all >2.5 times the upper limit of normal: if caused by liver metastasis, the above indicators are >5 times the upper limit of normal; 6.Renal function test: serum creatinine (Cr) > 1.5 times the upper limit of normal; 7.Individuals allergic to this product or other biologics derived from genetically engineered Escherichia coli. 8.Women who are pregnant or breastfeeding, or patients of childbearing potential who are unwilling to use contraception; 9.Patients with severe mental or neurological disorders, affecting informed consent and/or the expression or observation of adverse reactions; 10.The researchers believe that the individual is not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence of grade 3-4 neutropenia (ANC reduction);

Countries

China

Contacts

Public ContactCheng Shuxia

Henan Cancer Hospital

13653718356@139.com+86 371 65587558

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026