Telpegfilgrastim Injection to Reduce the Risk of Neutropenia in Patients With Solid Tumor
Recruiting now
Conditions studied: Chemotherapy-induced Neutropenia
In brief
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.
Key facts
- Study ID
- NCT07096479
- Run by
- Anhui Provincial Hospital
- People needed
- 318
- Starts
- 2024-08-15
- Expected to finish
- 2025-08-15
- Last updated by the study team
- 2025-07-31
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Anhui province hospital — Hefei, Anhui, China (enrolling)
- Anhui province hospital — Hefei, Anhui, China (enrolling)
Full record on ClinicalTrials.gov
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