RecruitingNot Applicable

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

China318 participantsStarted 2024-08-15

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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:
✕. 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.

What they're measuring

The incidence of grade ≥3 neutropenia during four chemotherapy cycles

Timeframe: At the end of each cycle (each cycle being 21 days)

Trial details

NCT IDNCT07096479

SponsorAnhui Provincial Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-08-15

View on ClinicalTrials.gov More Chemotherapy-induced Neutropenia trials