Actively Recruiting
Efbemalenograstim Alfa for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN
Led by Henan Cancer Hospital · Updated on 2025-09-23
1076
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
H
Henan Cancer Hospital
Lead Sponsor
W
West China Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Efbemalenograstim alfa for primary/secondary prevention in patients with solid tumors at high risk for febrile neutropenia (FN) or Intermediate risk of chemotherapy regimens associated with other risk factors in FN
CONDITIONS
Official Title
Efbemalenograstim Alfa for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign the informed consent form and be able to comply with the requirements of the protocol
- Age 18 years or older and 75 years or younger
- Patients with solid tumors confirmed by histopathology or cytology
- Cohort 1: No prior use of G-CSF drugs during this chemotherapy treatment
- Cohort 2: Experienced grade 3 or higher absolute neutrophil count reduction after first chemotherapy course and still at risk for subsequent chemotherapy
- Planned to receive at least 2 courses of chemotherapy regimens with high risk or intermediate risk with other risk factors for febrile neutropenia (including but not limited to age 65 or older, poor nutritional status, ECOG score 2 or higher)
- ECOG performance status score of 0 to 2
- Expected survival of at least 12 weeks
- Absolute neutrophil count (ANC) 2.0 x 10^9/L or higher, hemoglobin 90 g/L or higher, and platelet count 80 x 10^9/L or higher before enrollment
- Liver and kidney function within normal limits: total bilirubin no higher than 1.5 times upper limit, ALT and AST no higher than 2.5 times upper limit, serum creatinine no higher than 1.5 times upper limit
- Left ventricular ejection fraction 50% or higher
- Women of non-childbearing potential or use of adequate contraception if childbearing potential
- Investigator judges patient can tolerate treatment with Efbemalenograstim alfa
You will not qualify if you...
- Uncontrolled infection within 72 hours prior to chemotherapy or receiving systemic antibiotic therapy
- Pregnant or lactating women
- Previous bone marrow or stem cell transplantation
- Having two or more primary malignant tumors simultaneously except certain treated cancers with no evidence of recurrence
- Psychiatric or brain metastases
- Surgical procedure or trauma within 4 weeks
- Acute congestive heart failure, cardiomyopathy, or recent myocardial infarction
- Diseases that may cause spleen enlargement
- Acute infection or chronic active hepatitis B within 1 year unless negative for hepatitis B antigen
- Known HIV positive or AIDS
- Active tuberculosis or recent exposure unless negative tuberculin test
- Sickle cell anemia
- Known hypersensitivity to G-CSF drugs or their components
- Use of similar research drugs within 1 month prior to study
- Any other diseases or symptoms deemed unsuitable by investigator that may harm patient health or affect study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Henan cancer hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
Research Team
Z
Zhenzhen Liu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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