Clinical trial · Interventional
Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy
Multi-center, Randomized, Open-labeled, Positive-controlled, Phase Ⅱ Study to Evaluate Efficacy and Safety of YPEG-rhG-CSF, Once-per-cycle, Comparing to PEG-rhG-CSF, Once-per-cycle, in Chemotherapy-induced Neutropenia of Patients With Malignancies Receiving Myelosuppressive Chemotherapy.
NCT02005458CI-TRIAL-00033796completedPhase 2ClinicalTrials.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)
This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug | — | UNRESOLVED |
| YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug | — | UNRESOLVED |
| YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug | — | UNRESOLVED |
| YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- YPEG-rhG-CSF 20μg/kg
- description
- 20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
- interventionNames
- Drug: YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
- type
- EXPERIMENTAL
- label
- YPEG-rhG-CSF 30μg/kg
- description
- 30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle
- interventionNames
- Drug: YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
- type
- EXPERIMENTAL
- label
- YPEG-rhG-CSF 45μg/kg
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of non-small cell lung cancer or Breast cancer, and adequate for carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin chemotherapy * Karnofsky Score ≥ 70 * Life Expectancy \> 3 months * Age: 18～70yrs. * Peripheral blood test: WBC≥3.5×106/mm3, PLT≥100×106/mm3, ANC≥1.5×106/mm3; Normal bone marrow function; Bone marrow biopsy shows active hematopoietic without cancer cells. * Normal coagulation function, no evidences of hemorrhage tendency. * No exiting diseases or condition that may influence drug absorption, distribution, metabolism, and excretion. * Adequate liver, cardiac, kidney function. Indicators of liver function test ≤ 2.5ULN, Indicators of kidney function test ≤ 1ULN * Understand and voluntarily sign an informed consent form. Exclusion Criteria: * Pregnant or lactating females * Evidence of tumor metastasis in bone marrow * Lack insight due to tumor metastasis in the central nervous system * Prior bone marrow transplant or stem cell transplant * Infective symptom before enrollment into this study * Other malignancy history * Known hypersensitivity to any component of the drug(e.g. rh-G-CSF) that to be administered * Subject enrolled in any other investigational drug or device trial within 3 months of informed consent date * Drug abuser or alcoholist * Prior radiotherapy or expected to received radiotherapy * Unstable or uncontrolled cardiac or hypertension * Other conditions which in the opinion of the investigator preclude enrollment into the study
References
Publications (0)
Data not yet available
No reference posted for this study.