Clinical trial · Interventional
Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients
Efficacy and Safety Phase Ib Study of Recombinant Human Serum Albumin/ Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients
- 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 purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections. To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-induced Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rHSA/GCSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- single injection-1.8mg
- description
- rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day
- interventionNames
- Drug: rHSA/GCSF
- type
- EXPERIMENTAL
- label
- single injection-2.1mg
- description
- rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day
- interventionNames
- Drug: rHSA/GCSF
- type
- EXPERIMENTAL
- label
- single injection-2.4mg
- description
- rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-65. * Diagnosed breast cancer,received chemotherapy. * ECOG performance status 0 or 1. * ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency. * Leukocyte reduction occurred after chemotherapy,WBC≤3.0x109/L or ANC≤1.5x109/L. * No obvious abnormal ecg examination. * Cr,TBIL, AST, ALT≤1.5×ULN,no serious underlying disease. * Signed informed consent. Exclusion Criteria: * Chemotherapy within past 4 weeks. * Uncontrolled inflammatory disease,axillary temperature≥38℃. * Merging other malignant tumor. * Pregnancy or nursing status. * Participation in another clinical trial with and investigational product within 3 months prior to study entry. * Severe diabetes mellitus, or poor blood sugar controller. * Allergic disease or allergic constitution. History of protein allergy. * History of drug addiction and alcoholism. * Hematopoietic stem cell transplantation or organ transplantation. * Received antibiotic treatment within 72 hours before chemotherapy. * Long-term use of hormones or immunosuppressive agents. * Severe mental or neurological disorders. * Chronic disease of severe cardiac, kidney and liver. * Other conditions that would be excluded from this study according to doctors'judgment.
References
Publications (1)
- DERIVEDChen S, Han Y, Ouyang Q, Lu J, Zhang Q, Yang S, Wang J, Huang H, Liu H, Shao Z, Li H, Chen Z, Sun S, Geng C, Lu J, Sun J, Wang J, Xu B. Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy. BMC Cancer. 2021 Mar 31;21(1):341. doi: 10.1186/s12885-021-08093-z. PMID 33789616