Clinical trial · Observational
Telpegfilgrastim Injection to Reduce the Risk of Neutropenia in Patients With Solid Tumor
A Real World Study on the Efficacy and Safety of Telpegfilgrastim Injection for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Solid Tumor
NCT07096479CI-TRIAL-00092881recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Telpegfilgrastim Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The incidence of grade ≥3 neutropenia during four chemotherapy cycles
- timeFrame
- At the end of each cycle (each cycle being 21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.