Chemoradiotherapy, Myelosuppression, Thoracic Neoplasms
Conditions
Keywords
Neutropenia, Febrile neutropenia
Brief summary
This is a prospective observational study designed to observe and evaluate the safety and efficacy of mecapegfilgrastim in the treatment of moderate-to-severe myelosuppression associated with concurrent chemoradiotherapy. The project will provide more robust evidence-based medical support for the use of long-acting granulocyte-stimulating agents in patients undergoing concurrent chemoradiotherapy.
Detailed description
Group 1: Monitor the changes in neutrophil levels during the first follow-up cycle after enrollment in this study. When the neutrophil level falls below 1.5×10⁹/L, the investigator will communicate with the patient to determine whether to use conventional leukocyte-increasing drugs such as Licorice tablets. If so, the patient will be assigned to Group 1. Group 2: After enrollment in this study, the investigator will communicate with the patient to determine whether to use Sulfated PEG-Interferon injection to prevent and treat neutropenia. If so, 24 hours after the end of the chemotherapy cycle, the patient will receive a subcutaneous injection of Sulfated PEG-Interferon once. The recommended dose is a fixed dose of 6 mg per injection; or, based on the patient's weight, an individualized treatment dose of 100 μg/kg. The patient will then be assigned to Group 2.
Interventions
After enrollment, a single subcutaneous dose of mecapegfilgrastim should be administered 24 hours following completion of each chemotherapy cycle. The recommended dose is a fixed 6 mg, or an individualized 100 μg/kg based on the patient's body weight. If neutrophil counts remain below 0.5 × 10⁹/L for more than 24 hours after mecapegfilgrastim administration, short-acting G-CSF may be used as rescue therapy at the investigator's discretion until neutrophil levels return to normal.
DRUGOral or short-acting granulocyte-stimulating agents
In the first cycle after enrollment, patients will be followed for changes in neutrophil counts. Should the neutrophil level fall below 1.5 × 10⁹/L, the investigator may, based on clinical judgment, decide whether to intervene with leucogen tablets or other granulocyte-boosting agents. If the count remains below 1.0 × 10⁹/L, short-acting G-CSF may be administered as a rescue therapy.
Sponsors
Affiliated Hospital of Nantong University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-75 years at the time of giving informed consent， both sexes eligible * Histologically or cytologically confirmed thoracic tumor (esophageal or lung cancer) * Investigator judges the patient suitable for treatment with mecapegfilgrastim injection or leucogen tablets * Expected survival \> 3 months * Signed informed consent; willing and able to comply with protocol-mandated visits * The patient is indicated for concurrent chemoradiotherapy and is currently/receiving or will receive a high-risk chemotherapy regimen for febrile neutropenia (FN risk ≥20%), or is currently/receiving or will receive an intermediate-risk chemotherapy regimen for FN (FN risk 10%\ 20%) with additional FN risk factors.
Exclusion criteria
* Pregnant or lactating women * Known hypersensitivity to mecapegfilgrastim, pegylated or non-pegylated rhG-CSF, or any E. coli-derived product * Any severe comorbidity that, in the investigator's opinion, compromises patient safety or ability to complete the study * Any other condition that, in the investigator's judgment, could interfere with study conduct or interpretation of results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hematologic toxicity | Day 7,Day 14 | Hematologic toxicity, assessed by CBC performed 1 day before chemotherapy and on days 7 and 14 post-chemotherapy; CBC may be done at an external facility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of non-hematologic toxicity | Day 1, Day 7, and Day 14 of the first and second anti-tumor treatment cycles, and Day 30 after the completion of radiotherapy. | Secondary Outcome Measures: Non-hematologic toxicity On Day 1 of cycles 1 and 2: vital signs, complete blood count, urinalysis, stool routine, serum chemistry, coagulation panel, and 12-lead ECG. On Days 7 and 14 of cycles 1 and 2: repeat complete blood count only. All patient-reported adverse events are captured through 30 days after completion of radiotherapy. |
Countries
China
Contacts
Primary ContactZhiming CHEN
Outcome results
None listed