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Recruiting NCT07096479

Telpegfilgrastim Injection to Reduce the Risk of Neutropenia in Patients With Solid Tumor

Trial Parameters

Condition Chemotherapy-induced Neutropenia
Sponsor Anhui Provincial Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 318
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-08-15
Completion 2025-08-15
Interventions
Telpegfilgrastim Injection

Brief Summary

The objective of this real world study is to confirm the efficacy and saftey of Telpegfilgrastim injection for the prevention of chemotherapy-induced Neutropenia in Patients With Malignant solid tumor.

Eligibility Criteria

Inclusion Criteria: 1. Male or female, age ranging from 18 to 70 years old (excluding 70 years old); 2. body weight ≥45 kg; 3. Histologically or cytologically confirmed diagnosis of malignant solid tumor; 4. Solid tumor patients who receive a 3-week chemotherapy regimen have been evaluated as high-risk for FN or evaluated as having moderate risk for FN, but with an increased risk factor for neutropenia associated with the chemotherapy regimen;(The risk assessment of FN in tumor chemotherapy is based on " Chinese Society of Clinical Oncology (CSCO) guidelines for standardized management of tumor chemoradiotherapy related neutropenia(2021 edition)" and " Consensus on clinical diagnosis, treatment, and prevention of chemotherapy-induced neutropenia in China(2023 edition)"; 5. Karnofsky Performance Scale(KPS) score≥70; 6. The total number of white blood cells and absolute value of neutrophils before chemotherapy should not be lower than normal values: WBC ≥ 3.5 × 109/L, ANC ≥ 1.5 × 109/L;

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