NCT07096479 Telpegfilgrastim Injection to Reduce the Risk of Neutropenia in Patients With Solid Tumor
| NCT ID | NCT07096479 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anhui Provincial Hospital |
| Condition | Chemotherapy-induced Neutropenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 318 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2025-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 318 participants in total. It began in 2024-08-15 with a primary completion date of 2025-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07096479 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Chemotherapy-induced Neutropenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07096479 currently recruiting?
Yes, NCT07096479 is actively recruiting participants. Visit ClinicalTrials.gov or contact Anhui Provincial Hospital to inquire about joining.
Where is the NCT07096479 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China.
Who is sponsoring the NCT07096479 clinical trial?
NCT07096479 is sponsored by Anhui Provincial Hospital. The trial plans to enroll 318 participants.