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A multicenter, open, single arm study of the efficacy and safety analysis of PEGylated granulocyte colony-stimulating factor in preventing neutropenia after chemotherapy in patients with solid tumors

A multicenter, open, single arm study of the efficacy and safety analysis of PEGylated granulocyte colony-stimulating factor in preventing neutropenia after chemotherapy in patients with solid tumors

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019675
Enrollment
Unknown
Registered
2018-11-22
Start date
2018-11-21
Completion date
Unknown
Last updated
2018-11-26

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

Conditions

Neutrophil reduction after chemotherapy

Interventions

Case series:48h after chemotherapy, JinyouLi 3mg/times, 1 injection per chemotherapy cycle.

Sponsors

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged at least 18 years male or female; 2. Patients diagnosed with solid tumors by histopathology or cytology; 3. Patients requiring multiple cycles of chemotherapy alone; 4. 10% 2.0); (6) Renal dysfunction (Ccr 65 years receiving adequate dose-intensive chemotherapy; 5. KPS=70; 6. Life expectancy is more than 3 months; 7. Hematopoietic function: ANC =1.5×10^9/L; PLT=80×10^9/L; Hb= 75g/LWBC =3.0×10^9/L; 8. All patients must agree to take effective contraception during the study period and within 6 months of cessation of treatment, and women of childbearing age must have a negative urine pregnancy test before treatment; 9. All the subjects (or their legal representatives/guardians) were required to provide written informed consent prior to enrollment.

Exclusion criteria

Exclusion criteria: 1. Hematopoietic stem cell or organ transplant recipients; 2. Uncontrolled local or systemic infection; 3. Severe dysfunction of internal organs and myocardial infarction occurred in the past 6 months; 4. Liver function: TBIL, ALT and AST are all > 2.5 times the upper limit of normal, if the liver metastasis is due to the above indicators>5 times the upper limit of normal; renal function: Cr> 2 times the upper limit of normal; 5. Hypersplenism; 6. Use other drugs of the same type or clinical trials of other drugs within 4 weeks before enrollment; 7. Allergy to PEG-rhG-CSF, rhG-CSF, and other agents or proteins expressed in Escherichia coli; 8. Severe mental illness, affecting informed consent and/or describing or observing adverse reactions; 9. Pregnancy or breastfeeding women, women of childbearing age refused to accept contraceptives; 10. Patients who are not suitable for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
The incidence of III/IV ANC reduction in each chemotherapy cycle;

Secondary

MeasureTime frame
Incidence and duration of FN in each chemotherapy cycle;Chemotherapy dosage adjustment or delayed chemotherapy for each chemotherapy cycle;Proportion of patients receiving antibiotic treatment during chemotherapy;

Countries

China

Contacts

Public ContactHu Guangyuan

Tongji Hospital of Tongji Medical College, Huazhong

huguangyuan2018@sohu.com+86 13098834328

Outcome results

None listed

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