Appatinib Combined With S-1 in the Treatment of Small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the objective remission rate and disease control rate of apatinib mesylate tablets combined with S-1 in the treatment of advanced small cell lung cancer patients with failed or dangerous radiotherapy or chemotherapy

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

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Apatinib

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.