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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT04128800
Eligibility Criteria:
Inclusion Criteria:
1. The informed consent of the patient must be obtained before any research steps are carried out.
2. Confirmation of SCLC: Histological diagnosis or two imaging diagnoses must be made.
3. Late stage of SCLC, failure of second-line radiotherapy and chemotherapy or dangerous type of patients
4. Male or female subjects \> 18 years old, \< 75 years old
5. There are objective lesions that can be measured by CT.
6. The activity status of KPS was above 80 points.
7. Within 14 days before admission, the bone marrow, liver and kidney functions detected by the central laboratory should meet the following laboratory data requirements:
Hemoglobin ≥ 9.0 g/dl; absolute neutrophil count (ANC)1,500 /mm3 ; platelet count ≥ 50,000 /ul; total bilirubin \< 2 mg/dL (3 mg/dL, Child B); ALT and AST \< 5-fold normal value upper limit; alkaline phosphatase \< 4-fold normal value upper limit; PT \> 50% or PT-INR \< 2.3, or greater than the control value \< 6 seconds.
8. For subjects taking warfarin, the subjects were closely monitored at least once a week until the INR measurement of the subjects was stable at the time of each administration according to the local treatment standards.
9. The upper limit of normal serum creatinine \< 1.5 times is
10. For pregnant women, the results of serum pregnancy test must be negative within 14 days before the start of treatment.
11. All male and female patients participating in this study must adopt reliable contraceptive measures during the trial and within two week.
Exclusion Criteria:
1. KPS \< 60 points, or expected survival \< 3 months.
2. Severe cardiovascular diseases .
3. Uncontrollable hypertension .
4. History of human immunodeficiency virus (HIV) infection .
5. Active clinical severe infections (Grade 2, NCI-CTCAE Version 3.0) .
6. Epilepsy patients requiring medication (e.g. steroids or antiepileptic drugs) .
7. History of allogeneic organ transplantation .
8. Patients with signs of hemorrhage or history of disease.
9. Patients undergoing renal dialysis.
10. Chronic obstructive pulmonary emphysema .
11. Gastrointestinal bleeding within 30 days before admission .
12. Patients have a history of esophageal varices bleeding, and subsequently did not receive effective treatment or treatment to prevent recurrence of bleeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04128800
Study Brief:
Protocol Section:
NCT04128800