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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,076
The patients with solid tumor who were at high risk for febrile neutropenia or intermediate risk of chemotherapy regimens associated with other risk factors in febrile neutropenia would be injected Efbemalenograstim alfa for primary/secondary prevention.
The Henan cancer hospital
Zhengzhou, Henan, China
RECRUITINGCohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 1st cycle of chemotherapy
Time frame: Evaluate the incidence of grade ≥3 ANC at the end of Cycle 1 (Cycle 1 is 21 days)
Cohort 2: Incidence of ≥3 grade ANC reduction in patients after secondary prevention with Efbemalenograstim alfa after the 2nd cycle of chemotherapy
Time frame: Evaluate the incidence of grade ≥3 ANC at the end of Cycle 2 (Cycle 2 is 21 days)
Incidence of febrile neutropenia (FN) of each cycle of chemotherapy
Time frame: At the end of each cycle(each cycle is 21 days), an average of 3 months
Cohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 2nd/3rd/4th cycle of chemotherapy
Time frame: At the end of Cycle 2, 3 and 4 (each cycle is 21 days)
Cohort 2: Incidence of ≥3 grade ANC reduction in patients after secondary prevention with Efbemalenograstim alfa after the 3rd/4th cycle of chemotherapy
Time frame: At the end of Cycle 3, 4 (each cycle is 21 days)
Safety indicators
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Through study completion and 1 month post-treatment, an average of 4 months
Injectable antibiotic use rate in each chemotherapy cycle
Time frame: During the treatment of chemotherapy, an average of 3 months
The per capita number of doses of G-CSF products in each chemotherapy cycle
Time frame: During the treatment of chemotherapy, an average of 3 months
Incidence of chemotherapy dose reduction (10% ≥reduction in the dose of any chemotherapy drugs) and chemotherapy delay (≥ 2 days later than planned) due to neutropenia in each chemotherapy cycle
Time frame: During the treatment of chemotherapy, an average of 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.