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A single-center, open-arm, open-arm study was conducted to evaluate the efficacy and safety of polyethylene glycol recombinant human granulocyte stimulating factor injection (peg-rhg-csf) in preventing neutropenia in patients with cervical cancer during concurrent chemoradiotherapy and adjuvant chemotherapy

A single-center, open-arm, open-arm study was conducted to evaluate the efficacy and safety of polyethylene glycol recombinant human granulocyte stimulating factor injection (peg-rhg-csf) in preventing neutropenia in patients with cervical cancer during concurrent chemoradiotherapy and adjuvant chemotherapy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027429
Enrollment
Unknown
Registered
2019-11-13
Start date
2019-11-13
Completion date
Unknown
Last updated
2019-11-18

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

Conditions

cervical carcinoma

Interventions

Single arm:PEG-rhG-CSF

Sponsors

Gansu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 and = 70; 6. There was no obvious sign of hematological system disease, ANC >=1.5x 10^9 / L, platelet count >= 80 x 10^9 / L, Hb >= 90 g / L, and no bleeding tendency; 7. Patients sign informed consent.

Exclusion criteria

Exclusion criteria: 1. At present, there are uncontrollable infections or systemic antibiotic treatment within 72 hours before chemotherapy; 2. Any myelodysplasia or other hematopoiesis abnormality; 3. Patients who have received bone marrow or hematopoietic stem cell transplantation in the past 3 months; 4. The patients who had other malignant tumors before were not cured or had brain metastasis; 5. There is no serious cardiovascular disease such as cerebrovascular accident, myocardial infarction in recent 6 months, hypertension, unstable angina, heart failure (NYHA 2-4 grade) and arrhythmia requiring drug intervention; 6. Total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in liver function test were all more than 2.5 times of the upper limit of normal value; 7. Renal function test: serum creatinine (CR) > 1.5 times the upper limit of normal value; 8. Those who are allergic to this product or other biological products from genetically engineered Escherichia coli; 9. Those who suffer from mental or nervous system diseases and cannot cooperate; 10. The researchers think it is not suitable for the participants.

Design outcomes

Primary

MeasureTime frame
Incidence of grade III / IV neutropenia in each cycle supported by PEG rhG CSF;

Secondary

MeasureTime frame
Incidence of neutropenic fever (FN) supported by PEG rhG CSF;Proportion of dose adjustment of chemotherapy drugs caused by neutropenia in each cycle under the support of PEG rhG CSF;The incidence of delayed chemotherapy caused by neutropenia in each cycle supported by PEG rhG CSF;Antibiotic utilization rate in each cycle supported by PEG rhG CSF;

Countries

China

Contacts

Public ContactZhao Fengju

Gansu Cancer Hospital

854013603@qq.com+86 13919219021

Outcome results

None listed

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