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Chemotherapy-induced NeutropeniaNCT07096479

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

An observational study of Chemotherapy-induced Neutropenia, run by Anhui Provincial Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chemotherapy-induced Neutropenia
What is being tested?
Telpegfilgrastim Injection
Type of treatment
Injection or infusion
How many people
318 participants
Where
2 sitesChina
Study dates
15 Aug 2024to 15 Aug 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting
  • Anhui province hospital

    Hefei, Anhui, 230000

    Lianxin Liu, M.D., 13845159888, liulx@ustc.edu.cn

    Recruiting
  • Anhui province hospital

    Hefei, Anhui, 230000

    Ji-Zhou Wang, MD PhD, 13836135864, wangjoe@ustc.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Real World Study on the Efficacy and Safety of Telpegfilgrastim Injection for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Solid Tumor

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.

Read the detailed description

In recent years, the incidence rate of malignant tumors in China has increased year by year, and tumor treatment methods are also developing; However, various complications may still accompany the treatment of cancer patients, such as neutropenia, thrombocytopenia, nausea and vomiting. The treatment for neutropenia includes removal of the cause, supportive therapy, use of antibiotics, use of granulocyte colony-stimulating factor (G-CSF), oral medication, hematopoietic stem cell transplantation, hormone and immunotherapy, among which G-CSF is the most commonly used. At present, stratified management is recommended for chemotherapy-induced neutropenia, including primary prevention, secondary prevention, and treatment. For patients receiving high-risk chemotherapy regimens, prophylactic use of G-CSF is recommended, regardless of whether the treatment goal is to cure, prolong survival time, or improve disease-related symptoms. For patients receiving medium risk chemotherapy regimens, it is necessary to assess their own risk factors, such as patient age. If the patient meets any of the factors that increase the risk factor, it is recommended to use G-CSF preventively. The definition of secondary prevention of neutropenia is that if a patient develops FN or dose limiting neutropenia in the previous chemotherapy cycle, prophylactic use of G-CSF can be considered in the next chemotherapy cycle. For patients who have not received prophylactic use of G-CSF, a risk assessment of therapeutic use of rhG CSF should be conducted. If there are adverse factors, rhG CSF treatment should be considered.

Telpegfilgrastim is a Y-shaped polyethylene glycol (PEG) modified human granulocyte colony-stimulating factor (rhG-CSF) that has been approved by the NMPA for "reducing the incidence of infections manifested as febrile neutropenia in patients with non myeloid malignancies receiving bone marrow suppressive anticancer drugs that are prone to clinically significant febrile neutropenia. " Compared with the existing straight chain PEG rhG CSF in clinical practice, the Y-shaped branch structure of Telpegfilgrastim affects the activity and metabolic rate of the drug to a certain extent. While prolonging the half-life of the drug, the dosage is also significantly lower than that of long-acting products already on the market. It can be administered preventively after chemotherapy, maintaining the effective blood drug concentration throughout the entire cycle and effectively preventing the occurrence of neutropenia. Due to the reduction in medication dosage, the incidence of side effects such as skeletal and muscle pain is correspondingly reduced, resulting in better safety performance.

Being tested
Telpegfilgrastim Injection
Keywords
Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telpegfilgrastim InjectionDrug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of grade ≥3 neutropenia during four chemotherapy cycles

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start15 Aug 2024
  3. Primary completion15 Aug 2025 (estimated)
  4. Study completion15 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
318 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07096479
Sponsor's protocol ID
PJ-B-05
Status last verified
Jul 2025
First submitted
5 Aug 2024
Last updated
31 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chemotherapy-induced Neutropenia, run by Anhui Provincial Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of grade ≥3 neutropenia during four chemotherapy cycles (time frame: At the end of each cycle (each cycle being 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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