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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorAnhui Provincial Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)";

Disqualifiers

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);

Pregnant or breastfeeding woman ;

Trial population

Solid tumor patients who require chemotherapy (chemotherapy regimen for FN high-risk or FN medium risk accompanied by increased risk factors)

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Telpegfilgrastim Injection

    Drug

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

The incidence of grade ≥3 neutropenia during four chemotherapy cycles

Time frame
At the end of each cycle (each cycle being 21 days)

Secondary outcomes

Other outcomes

Sponsors and contacts

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