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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT04073550
Eligibility Criteria:
Inclusion Criteria:
1. Small cell lung cancer patients.
2. The clinical stage at baseline is extensive.
3. A measurable lesion.
4. Disease progression.
5. ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
6. Adequate laboratory indicators.
7. No pregnant or breastfeeding women, and a negative pregnancy test.
8. Understood and signed an informed consent form.
Exclusion Criteria:
1. Has used topotecan and anlotinib hydrochloride capsules.
2. Has used other anti-angiogenic drugs and immunologically targeted drugs.
3. Has other malignant tumors within 5 years.
4. Symptomatic brain metastasis.
5. Has a variety of factors affecting oral medications.
6. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
7. Spinal cord compression.
8. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
9. Adverse events caused by previous treatment did not recover to grade 1.
10. Has received major surgical treatment within 4 weeks before randomization.
11. Arteriovenous thrombosis occurred within 6 months.
12. Has drug abuse history that unable to abstain from or mental disorders.
13. Has severe or uncontrolled disease.
14. Participated in other clinical trials within 4 weeks.
15. Tumor invades the large blood vessels.
16. Daily hemoptysis ≥2.5 mL within 1 month before the first dose.
17. According to the investigators' judgement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04073550
Study Brief:
Protocol Section:
NCT04073550