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 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT03776604
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 70 years old, gender is not limited;
* Small cell lung cancer patients diagnosed by histopathology or cytology;
* ECOG = 0-1;
* The estimated survival period is more than 3 months;
* No obvious signs of hematological disease, defined as Hb≥90g/dL, WBC≥4.0×10\^9/L, ANC≥2×10\^9/L, PLT≥100×10\^9/L before enrollment. And no bleeding tendency;
* No obvious abnormalities were observed in the electrocardiogram examination;
* Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of normal values. If due to liver metastasis, the above indicators should be within 5 times of the upper limit of normal. If LDH is elevated due to non-tumor causes, LDH should be ≤ 2.5 times the upper limit of normal; if LDH is elevated due to tumor, it can be enrolled;
* Renal function test BUN, UA within 1.5 times the upper limit of normal value, creatinine clearance rate\> 60ml / min;
* Subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.
Exclusion Criteria:
* There are currently uncontrollable infections, body temperature ≥ 38.0 ° C;
* Patients with previous malignant tumors that have not been cured or have bone marrow metastasis;
* Patients with prophylactic antibiotics;
* Accepting other test drugs at the same time or participating in other clinical trials;
* Those who are allergic to this product or other genetically engineered E. coli-derived biological products;
* The patient has any myelodysplastic and other blood system diseases;
* Patients who have received hematopoietic stem cell transplantation or organ transplantation;
* The patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT03776604
Study Brief:
Protocol Section:
NCT03776604