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

NCT07096479 | Recruiting

• 1 other identifier: PJ-B-05
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chemotherapy-induced Neutropenia

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• The incidence of grade ≥3 neutropenia during four chemotherapy cycles

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (2)

Anhui province hospital

Hefei, Anhui, 230000, China

RECRUITING

Anhui province hospital

Hefei, Anhui, 230000, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: July 31, 2025
• Study Start: August 15, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)