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Efficacy and safety of pegfilgrastim for prophylactic chemoradiotherapy in patients with cervical cancer

Efficacy and safety of pegfilgrastim for prophylactic chemoradiotherapy in patients with cervical cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021410
Enrollment
Unknown
Registered
2019-02-20
Start date
2019-02-09
Completion date
Unknown
Last updated
2019-02-25

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

Conditions

Cervical cancer

Interventions

Case series:Subcutaneous injection of pegfilgrastim 24-72 hours after chemotherapy

Sponsors

General Hospital of Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old; 2. Patients with cervical cancer diagnosed by histopathology; 3. Patients requiring multi-cycle concurrent chemoradiotherapy; 4. Patients without serious complications; 5. Physical status (KPS) Score =70 points; 6. No obvious signs of hematological disease, before the enrollment ANC =1.5×10^9 /L, platelet count =80×10^9/L, Hb = 75 g/L, and no bleeding tendency; 7. Patient signing Informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are currently uncontrollable infections, or systemic antibiotics within 72 hours of receiving chemotherapy; 2. Any abnormal bone marrow hyperplasia and other hematopoietic dysfunction; 3. Patients who have received bone marrow or hematopoietic stem cell transplantation within the past 3 months; 4. Patients with previous malignant tumors who have not been cured or have brain metastases; 5. Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST) >2.5 times the upper limit of normal; if due to liver metastasis, the above indicators >5 times the upper limit of normal; 6. Renal function test: serum creatinine (Cr) > 1.5 times the upper limit of normal; 7. Those who are allergic to this product or other genetically engineered E. coli-derived biological products; 8. Suffering from mental or neurological disorders, unable to cooperate; 9. Researchers believe that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Incidence of grade III/IV neutropenia in each cycle of chemotherapy;

Secondary

MeasureTime frame
Dynamic changes in patient ANC (absolute neutrophil count);Incidence of neutropenic fever (FN) in each cycle of chemotherapy;Proportion of dose adjustment of chemotherapy drugs caused by neutropenia in each cycle of chemotherapy;Incidence of delayed chemotherapy caused by neutropenia in each cycle of chemotherapy;Patient hospitalization rate;antibiotic utilization rate;Occurrence and severity of adverse reactions;

Countries

China

Contacts

Public ContactFang Liu

General Hospital of Chinese People's Liberation Army?

liufangfsq@163.com+86 13520469875

Outcome results

None listed

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