To hear about similar clinical trials, please enter your email below
Trial Title:
Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints
NCT ID:
NCT06616571
Condition:
Chemotherapy-Induced Febrile Neutropenia
Conditions: Official terms:
Neutropenia
Febrile Neutropenia
Chemotherapy-Induced Febrile Neutropenia
Conditions: Keywords:
Febrile Neutropenia, Breast Cancer, Chemotherapy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QL0605(PEG-rhG-CSF)
Description:
Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks.
During each chemotherapy cycle QL0605 is injected 24 hours s.c. post chemotherapy
application.
Arm group label:
24h group
Arm group label:
48h group
Intervention type:
Drug
Intervention name:
QL0605(PEG-rhG-CSF)
Description:
Eligible patients are scheduled to receive 2 cycles of chemotherapy every three weeks.
During each chemotherapy cycle QL0605 is injected 48 hours s.c. post chemotherapy
application.
Arm group label:
24h group
Arm group label:
48h group
Summary:
The goal of this real-world study is to compare the efficacy and safety of QL0605
administered 24 hours and 48 hours after chemotherapy in breast cancer patients.
Detailed description:
Patients with stage invasive breast cancer who were scheduled to receive at least 2
cycles of adjuvant or neoadjuvant chemotherapy with TAC/TC/TCbH regimen were eligible for
this multicenter, open-label, randomized trial. Patients were randomized (2:1) to receive
QL0605 24 hours (24h group) or 48 hours (48h group) after the end of each cycle of
chemotherapy. The primary endpoint was the incidence rate of FN for cycle 1. The
secondary endpoints included the incidence rates of grade 3/4 neutropenia, chemotherapy
dose reduction and chemotherapy delay due to neutropenia, antibiotic administration, the
pain (bone, muscle, or joint), ect.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged≥18 years；
- The expected survival period is more than 3 months;
- ECOG≤ 2;
- Invasive breast cancer diagnosed by histopathology;
- Plan to receive TAC, TC or TCbH chemotherapy;
- Subjects with good hematology, liver, lung and kidney function ;
- Signed informed consent.
Exclusion Criteria:
- Known hypersensitivity to rhG-CSF or PEG-rhG-CSF;
- Female patients during pregnancy or lactation;
- The previous malignant tumors were not cured;
- Received chemotherapy or radiotherapy within 4 weeks before screening;
- Received PEG-rhG-CSF within 6 weeks before screening;
- Suffering from uncontrollable infectious diseases within 2 weeks before screening.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Wangwang Zhi
Start date:
September 19, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06616571
