Clinical trial · Interventional
PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy
The Multi-center,Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lung Cancer,Head and Neck Cancer,Colorectal Cancer,Ovarian Cancer and the Other Cancer Receiving Chemotherapy
NCT02805166CI-TRIAL-00022625completedPhase 4ClinicalTrials.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 purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.
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 |
|---|---|---|---|
| Malignant Solid Tumors | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-rhG-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-rhG-CSF
- description
- patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.
- interventionNames
- Drug: PEG-rhG-CSF
Primary outcomes (2)
- measure
- The occurrence rate of adverse event during at least three consecutive cycles chemotherapy
- timeFrame
- up to 30 days after the patient study completion
- measure
- The severity of adverse event during at least three consecutive cycles chemotherapy
- timeFrame
- up to 30 days after the patient study completion
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with age ≥ 18 years * diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer * Karnofsky Performance Status ≥ 70 * life expectancy of at least 3 months * Written informed consent are acquired Exclusion Criteria: * uncontrolled infection,Temperature is 38.0 ℃ or higher * pregnancy * Other situations that investigators consider as contra-indication for this study
References
Publications (0)
Data not yet available
No reference posted for this study.