RecruitingNCT07096479

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

A Real World Study on the Efficacy and Safety of Telpegfilgrastim Injection for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Solid Tumor

Sponsor

Anhui Provincial Hospital

Enrollment

318 participants

Start Date

Aug 15, 2024

Study Type

OBSERVATIONAL

Conditions

Chemotherapy-induced Neutropenia

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

Male or female, age ranging from 18 to 70 years old (excluding 70 years old);
body weight ≥45 kg;
Histologically or cytologically confirmed diagnosis of malignant solid tumor;
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)";
Karnofsky Performance Scale(KPS) score≥70;
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;
Subject has a life Expectation of at least 6 month；
Subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent for.

Exclusion Criteria8

Received any other PEG-rhG-CSF within 4 weeks prior to participating in this study;
Patients receiving intermittent or continuous chemotherapy regimens such as albumin paclitaxel and capecitabine;
Previously or expected to receive extensive radiation therapy (>25% of total bone marrow);
Individuals with significant functional impairments in important organs such as the heart, lungs, liver, and kidneys:
Liver function indicators (ALT, TBil)>2.5 ULN; Tumor patients with liver metastasis have liver function indicators (ALT,TBil)>5ULN; Hepatitis B virus infection, hepatitis C virus infection, or cirrhosis; Renal function Cr>1.5ULN;
Pregnant or breastfeeding woman ;
hypersensitive to rhG-CSF or other biological agents;
Investigators judged other situations that may affect the progress and results of clinical research.

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Interventions

DRUGTelpegfilgrastim Injection

Within 48 ± 12 hours after the end of each chemotherapy cycle, a single subcutaneous injection of a fixed dose of 2mg of Telpegfilgrastim is administered. Use once per chemotherapy cycle and enroll in 1-4 cycles based on the patient's actual condition.