Clinical trial · Interventional
To Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Reducing Neutropenia in Patients With Cervical Cancer
A Prospective, Open, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF in Reducing Neutropenia in Patients With Cervical Cancer
- 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)
A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-rhG-CSF | Drug | — | UNRESOLVED |
| rhG-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PEG-rhG-CSF
- description
- PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy,with patients' weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight \<45kg were given 3mg once per chemotherapy cycle.
- interventionNames
- Drug: PEG-rhG-CSF
- type
- ACTIVE_COMPARATOR
- label
- rhG-CSF
- description
- rhG-CSF was daily administered subcutaneously 48h after chemotherapy,weight≥45kg were given 300μg/d, weight\<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10\^9/L.
- interventionNames
- Drug: rhG-CSF
Primary outcomes (1)
- measure
- Incidence of III/IV neutropenia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18, ≤70 years old; 2. Cervical cancer patients diagnosed by histopathology; 3. Need to receive multi-cycle radical concurrent radiochemotherapy; 4. FN risk \> 20% if rhG-CSF was not accepted; High risk factors associated with FN and planed to use the same protocol in subsequent cycles(docetaxel+cisplatin regimen); 5. Performance status score(KPS)≥70; 6. No obvious blood system disease,absolute neutrophil count(ANC)≥ 1.5×10\^9/L, platelet count≥80×10\^9 /L, hemoglobin(Hb)≥75 g/L, and no bleeding tendency; 7. The patient signs the informed consent. Exclusion Criteria: 1. With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy; 2. Any bone marrow abnormalities and other hematopoietic ; 3. Had received bone marrow or hematopoietic stem cell transplantation within 3 months; 4. with other malignancies not cure, or with brain metastases; 5. Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≥2.5 times normal upper limit. 6. Renal function tests: serum creatinine (Cr)\> 1.5 times normal upper limit; 7. Allergic to the drugs or other genetic engineering biological products from Escherichia coli; 8. Suffering from mental or neurological disorders; 9. Investigator think it is not suitable for recruiting.
References
Publications (0)
Data not yet available