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A retrospective study of the efficacy and safety of toppefilgrastim injection in the prevention of neutropenia after chemotherapy in patients with solid tumors

A retrospective study of the efficacy and safety of toppefilgrastim injection in the prevention of neutropenia after chemotherapy in patients with solid tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095269
Enrollment
Unknown
Registered
2025-01-03
Start date
2025-01-03
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Neutropenia due to chemotherapy for tumors

Interventions

Observation group:None

Sponsors

Sun Yat-sen University Cancer Center (Sun Yat-sen University Affiliated Cancer Hospital, Sun Yat-sen University Cancer Institute)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with > age=18 years old; 2. Confirmed diagnosis of solid tumor by pathological histology or cytology; 3. Patients with solid tumors receiving 3-week regimen chemotherapy or 4-week regimen chemotherapy; 4. Patients who need to undergo primary prevention (use of G-CSF 24~72h after the first use of chemotherapy drugs with myelosuppression to prevent the occurrence of febrile neutropenia (FN)) or secondary prevention (if the patient developed FN or dose-limiting neutropenia in the previous chemotherapy cycle, the next chemotherapy cycle can be considered for prophylactic use of G-CSF); (Febrile neutropenia (FN): oral temperature > 38.3°C (axillary temperature >38.1°C) or oral temperature > 38.0°C (axillary temperature > 37.8°C) measured twice in 2 hours with an ANC =3.5×10 9/L, ANC>=1.5×10 9/L.

Exclusion criteria

Exclusion criteria: 1. Have received any antibody-drug conjugate (ADC) drugs and other drugs with potential blood toxicity; 2. Patients receiving intermittent or continuous chemotherapy regimens such as nab-paclitaxel and capecitabine; 3. Received extensive radiotherapy (>25% of total bone marrow); 4. Patients with obvious dysfunction of important organs such as heart, lung, liver, kidney, etc.: liver function index (ALT, TBil) > 2.5ULN, liver function index (ALT, TBil) >5ULN in patients with tumor metastasis, hepatitis B virus infection, hepatitis C virus infection or liver cirrhosis; Renal function Cr>1.5ULN; 5. Pregnant or lactating female patients; 6. Patients who have a clear refusal of clinical examination data for medical research in the patient's medical record.

Design outcomes

Primary

MeasureTime frame
Incidence of grade 3 and above neutropenia during chemotherapy cycles.;

Secondary

MeasureTime frame
Incidence of febrile neutropenia (FN) during chemotherapy cycles;Antibiotic use and incidence of infection;;Incidence of chemotherapy drug taper due to neutropenia;;Incidence of chemotherapy delay due to FN or infection;;The rate and length of hospitalization associated with CIN;;

Countries

China

Contacts

Public ContactShi Yanxia

Sun Yat-sen University Cancer Center

shiyx@sysucc.org.cn+86 13609058827

Outcome results

None listed

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