Anlotinib in Treatment of Recurrent Small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Exploring the efficacy and safety of Anlotinib in patients with relapsed small cell lung cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Cancer Hospital

Criteria

Inclusion Criteria:

1. Age ≥ 18 years old;

2. Histological or cytologically confirmed small cell lung cancer;

3. Systemic chemotherapy that has previously received at least two or more lines regimen, followed by disease progression or recurrence;

4. According to the RECIST 1.1 standard, there is at least one measurable target lesion;

5. ECOG physical score 0-1 points; expected survival time ≥ 3 months;

6. The main organ function meets the following criteria:

1. blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L;

2. Blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;

7. Subjects voluntarily joined the study and signed informed consent, with good adherence and follow-up.

Exclusion Criteria:

1. Subjects who have previously used Anlotinib;

2. Systematic anti-tumor treatments have been performed for the past 2 weeks, including chemotherapy, radiotherapy (except for metastatic lesions other than thoracic radiation), targeted therapy, immunotherapy, and biotherapy;

3. Imaging (CT or MRI) shows central tumors in which tumor lesions invade local large blood vessels; imaging (CT or MRI) shows significant pulmonary cavitary or necrotizing tumors; or other factors identified by the investigator that may cause hemoptysis disease;

4. A history of active bleeding within the first 6 months of screening, or receiving thrombolysis or anticoagulant therapy, or the investigator believes that there is a clear tendency to gastrointestinal bleeding (such as esophageal varices with bleeding risk, local activity) Ulcer lesions, etc.) or active hemoptysis;

5. A thrombotic event occurs within 6 months (including arteriovenous thrombosis, pulmonary embolism, cerebrovascular accident, including transient ischemic attack, etc.);

6. Cardiac diseases with obvious clinical symptoms, such as: congestive heart failure, coronary heart disease with obvious symptoms, arrhythmia with difficult drug control (including clinically significant QTc interval prolongation history, or screening period QTc interval women >470ms, Male > 450ms), had myocardial infarction within 6 months, or cardiac insufficiency;

7. Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;

8. Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy;

9. Surgery (<28 days) before the study was selected or the surgical incision did not completely heal, or there were other unhealed wounds;

10. Active or uncontrolled serious infections;

11. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;

12. Increasing the risk associated with participating in a study or study drug, and at the discretion of the investigator, may lead to other conditions in which the patient is not eligible for inclusion in the study.