Small cell lung cancer
Conditions
Interventions
Case series:Apatinib combined with paclitaxel liposome
Sponsors
Cancer hospital of Shantou University Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed SCLC diagnosis; 2) disease progression during or after first-line treatment with EP/EC/IP/IC regimen; 3) Aged 18 to 70 years old; 4) ECOG physical status = 3 months; 6) Male or non-pregnant, non-lactating female patients; 7) Hematological function: A. Platelet count >= 100 x 10^9/L. Note: Blood transfusion or thrombocytopenic factor is prohibited to reach the baseline platelet count standard. B. Absolute count of neutrophils (ANC) >= 1.0 x 10^9/L. Note: growth factors are prohibited to maintain ANC standards C. Hemoglobin >= 90 g/L; 8) Liver and kidney function: (1) Serum creatinine =50 mL /min; (2) Total bilirubin 1.5 ULN; (3) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3 ULN, or ALT and AST<=5 ULN when determined by the investigator to be elevated due to liver metastasis of the tumor; (4) Coagulation function: partial prothrombin kinase time (APTT) and prothrombin time (PT) <=1.2 ULN; 9) Patients with BMs whose clinical neurological symptoms are under control are defined as those who have maintained stable neurological function for 21 days after surgical resection and/or radiotherapy and who have no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first treatment of the study drug; 10) Men, women of child-bearing age (postmenopausal women must have been menopausal for at least 12 months to be considered infertile) and their partners voluntarily use contraceptives considered to be effective by the Investigator during treatment and for at least three months after the last use of the study drug; 11) Able to understand and voluntarily sign written informed consent which must be signed prior to the execution of any study procedure specified by the trial; 12) Patients must be willing and able to complete study procedures and follow-up examinations.
Exclusion criteria
Exclusion criteria: 1) Other malignancies were diagnosed or treated within 5 years prior to randomization (excised basal cell carcinoma of the skin or other carcinoma in situ were not included); 2) Before enrolment in this study, he had used Taxanes; 3) Patients with hypertension who cannot be reduced to the normal range after antihypertensive medication (systolic blood pressure>140 mmHg/diastolic pressure > 90 mmHg), acuity level II coronary heart disease, arrhythmia (including QTc lengthenedmen> 450 ms, women > 470 ms) and cardiac insufficiency; 4) There are many factors that affect the absorption of oral drugs (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction); 5) Special note: patients at risk of gastrointestinal bleeding were not included, including the following: (1) active lesion of digestive ulcer and fecal occult blood (++); (2) Patients with a history of melena or hematemesis within 3 months;For stool occult blood (+) - and the primary gastric tumor lesions have not been surgically removed, gastroscopy must be performed, such as ulcerative gastric cancer, and the treating physician believes that the lesions may cause hemorrhage; 6) Coagulation dysfunction (INR>1.5 ULN, APTT>1.5 ULN), with bleeding tendency; 7) Symptomatic central nervous system metastasis; 8) Pregnant or lactating women; 9) Other patients deemed unsuitable for inclusion by attending physicians. The Ethics Committee of Clinical Pharmaceutical Trail Institute, Cancer Hospital of Shantou University Medical College.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;OS;HRQoL;Safety;Tolerability; | — |
Countries
China
Contacts
Public ContactZhifeng Li
Cancer Hospital of Shantou University Medical College
Outcome results
None listed