Status:
UNKNOWN
Appatinib Combined With S-1 in the Treatment of Small Cell Lung Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 r...
Detailed Description
Lung cancer is one of the malignant tumors with the highest morbidity and mortality in the world. Small cell lung cancer accounts for about 15-20% of all lung cancer. Although the initial treatment is...
Eligibility Criteria
Inclusion
- The informed consent of the patient must be obtained before any research steps are carried out.
- Confirmation of SCLC: Histological diagnosis or two imaging diagnoses must be made.
- Late stage of SCLC, failure of second-line radiotherapy and chemotherapy or dangerous type of patients
- Male or female subjects \> 18 years old, \< 75 years old
- There are objective lesions that can be measured by CT.
- The activity status of KPS was above 80 points.
- 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.
- 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.
- The upper limit of normal serum creatinine \< 1.5 times is
- For pregnant women, the results of serum pregnancy test must be negative within 14 days before the start of treatment.
- All male and female patients participating in this study must adopt reliable contraceptive measures during the trial and within two week.
Exclusion
- KPS \< 60 points, or expected survival \< 3 months.
- Severe cardiovascular diseases .
- Uncontrollable hypertension .
- History of human immunodeficiency virus (HIV) infection .
- Active clinical severe infections (Grade 2, NCI-CTCAE Version 3.0) .
- Epilepsy patients requiring medication (e.g. steroids or antiepileptic drugs) .
- History of allogeneic organ transplantation .
- Patients with signs of hemorrhage or history of disease.
- Patients undergoing renal dialysis.
- Chronic obstructive pulmonary emphysema .
- Gastrointestinal bleeding within 30 days before admission .
- Patients have a history of esophageal varices bleeding, and subsequently did not receive effective treatment or treatment to prevent recurrence of bleeding.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04128800
Start Date
October 1 2019
End Date
December 1 2021
Last Update
October 16 2019
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060