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.
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
- 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
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.
- Conditions
- Chemotherapy-induced Neutropenia
- 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.
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.
- First posted31 Jul 2025
- Study start15 Aug 2024
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced NeutropeniaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lianxin Liu,PhD, Anhui Provincial Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07096479
- Acronym / sponsor ID
- PJ-B-05
- Conditions
- Chemotherapy-induced Neutropenia
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- 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)
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telpegfilgrastim InjectionWithin 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. | Drug | – |
Primary outcome
The incidence of grade ≥3 neutropenia during four chemotherapy cycles
Time frame: At the end of each cycle (each cycle being 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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.