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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT03700359
Eligibility Criteria:
Inclusion Criteria:
1. Histopathologically confirmed patients with extensive small cell lung cancer;
2. Karnofsky performance status ≥70;
3. At least one lesion that can measured by CT;
4. Expected to survive for at least 3 months;
5. Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment);
* White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L;
* Hemoglobin (HGB) ≥80 g/L；
* Platelet (PLT) ≥100×109/L;
* Liver transaminases（AST/ALT）\<3.0 times the normal range limit;
* Total bilirubin（TBIL）\<1.5 times the normal range limit;
* Creatinine（CREAT）\<1.5 times the normal range limit;
6. Patients of childbearing age (including female and male patients' partner) must take effective contraception methods;
7. Signed informed consent;
8. Known history of liver disease: Hepatitis B Virus (HBV) infection and Hepatitis B Virus DNA (HBV DNA ≥500 copies or ≥100 IU/ml); or Hepatitis C Virus (HCV) infection; or liver cirrhosis, etc.
9. Human immunodeficiency virus (HIV);
10. Subjects with difficulties in swallowing or known drug malabsorption; Those who meet each of the above criteria are included in the study.
Exclusion Criteria:
1. Other pathological types of tumor except for small cell lung cancer;
2. Patients with a history of severe allergies or allergies;
3. Pregnancy or breastfeeding women;
4. Patients who have previously participated in other clinical trials and have not yet terminated the trial;
5. Combined with other tumors at the time of initial diagnosis;
6. Patients who have previously participated in other clinical trials and have not yet terminated the trial;
7. Patients who have acute infection that difficult to control;
8. Drug abuse, substance abuse, chronic alcohol abuse, and AIDS patients. Those who meet any of the above criteria are not included in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03700359
Study Brief:
Protocol Section:
NCT03700359