Telpegfilgrastim to prevent neutropenia in people with solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a real-world observational study collecting safety and effectiveness data on telpegfilgrastim given to adults with confirmed malignant solid tumors receiving 3-week chemotherapy regimens and judged to be at high risk for febrile neutropenia or at intermediate risk with additional risk factors. Eligible participants are 18–69 years old, weigh at least 45 kg, have KPS ≥70, and have normal baseline WBC and ANC. Investigators will record incidence of neutropenia, febrile neutropenia, infections, chemotherapy dose delays or reductions, and adverse events during routine clinical care. Data will be used to confirm whether telpegfilgrastim reduces clinically meaningful neutropenia and is well tolerated in this patient population.

Why it matters

Who can join: the full rules

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;
7. Subject has a life Expectation of at least 6 month；
8. Subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent for.

Exclusion Criteria:

1. Received any other PEG-rhG-CSF within 4 weeks prior to participating in this study;
2. Patients receiving intermittent or continuous chemotherapy regimens such as albumin paclitaxel and capecitabine;
3. Previously or expected to receive extensive radiation therapy (\>25% of total bone marrow);
4. 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;
5. Pregnant or breastfeeding woman ;
6. hypersensitive to rhG-CSF or other biological agents;
7. Investigators judged other situations that may affect the progress and results of clinical research.

Where it's running

• Anhui province hospital
  Hefei, Anhui, China Recruiting
• Anhui province hospital
  Hefei, Anhui, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.