Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT02005458
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02005458
Study Brief:
Protocol Section:
NCT02005458