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:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT07145333
Eligibility Criteria:
* Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy
* Dosage Duration at least 45 days
* The usual approach group - Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Topotecan Capsule after lung tissue biopsy, like as the usual approach group.
* The study approach group - Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Topotecan Capsule after lung tissue biopsy, like as the study approach group.
Inclusion Criteria:
* 1\. Clinical diagnosis of Small Cell Lung Cancer (SCLC)
* 2\. Clinical lung tissue biopsy diagnosis of SCLC
* 3\. Suitable for enough lung tissue biopsy of SCLC
* 4\. Random and double blind
* 5\. Measurable disease
* 6\. Adequate organ functions
* 7\. Adequate performance status
* 8\. Age 24 years old and over
* 9\. Sign an informed consent form
* 10\. Receive blood-drawing
Exclusion Criteria:
* 1\. Pneumonectomy
* 2\. Treatment with other anti-cancer therapies and cannot be stopped currently
* 3\. Pregnancy
* 4\. Breast-feeding
* 5\. The patients with other serious intercurrent illness or infectious diseases
* 6\. Have more than one different kind of cancer at the same time
* 7\. Serious Allergy to Drugs
* 8\. Clot or Bleed Tendency
* 9\. Serious Risks or Serious Adverse Events of the drug product
* 10\. The prohibition of drug products
* 11\. Have no therapeutic effects
* 12\. Follow up to the most current label
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Years
Maximum Age:
64 Years
Study:
NCT07145333
Study Brief:
Protocol Section:
NCT07145333