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A perspective, single-arm trial for evaluating efficacy and safety of Jinyouli (PEG-rh-CSF) to prevent neutropenia with radiation and chemotherapy of TP regimen for cervical cancer

A perspective, single-arm trial evaluating efficacy and safety of Jinyouli (PEG-rh-CSF) to prevent neutropenia with radiation and chemotherapy of TP regimen for cervical cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024494
Enrollment
Unknown
Registered
2019-07-13
Start date
2019-07-10
Completion date
Unknown
Last updated
2019-07-15

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:rhG-CSF

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. histologically confirmed squamous cell carcinoma of the cervix (2018 FIGO stage IIIC1, IIIC2, IVA); 3. According to the researcher's judgment, if rh-CSF is not accepted, the risk of FN is >20%. with Risk factors of FN; and chemotherapy regimen (paclitaxel/paclitaxel liposome + cisplatin) is planned; 4. KPS score >=70; 5. ANC>=2.0x10^9/L, HB>=80g/L, PLT>=90x10^9/L; 6. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Currently has uncontrolled infection, or has been treated with systemic antibiotics within 72 h prior to chemotherapy; 2. Bone marrow dysplasia and other hematopoietic abnormalities; 3. Previous bone marrow or hematopoietic stem cell transplantation within 3 months; 4. Previously had other malignant tumors that were not cured or had brain metastases; 5. Total bilirubin (TBIL), alanine aminotransferase (ALT) and AST are >2.5 times the upper limit of normal value in liver function examination; 6. Renal function examination: upper limit of 1.5 normal serum creatinine (Cr); 7. Allergic to this product or other biological products from genetically engineered escherichia coli; 8. Suffering from mental or neurological disorders and unable to cooperate; 9. Pregnant or lactating female patients; Women in pregnancy age refusing to accept contraception; 10. Unsuitable for inclusion by researchers.

Design outcomes

Primary

MeasureTime frame
incidence of level III or IV neutropenia;

Countries

China

Contacts

Public ContactXiaofan Li

Beijing Cancer Hospital

lxflp@163.com+86 010 88196991

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026