Non-scale non-small cell lung cancer
Conditions
Interventions
Case series:Apatinib monotherapy for maintenance treatment
Sponsors
Xinqiao Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed stage IIIB-IV non-squamous non-small cell lung cancer; 2. At least one measurable lesion; 3. If the genetic test (EGFR/ALK) is an EGFR-sensitive mutation or an ALK fusion gene-positive patient, it is necessary to receive targeted therapy for the first-line treatment; if there is no mutation, it is necessary to be a first-line patient; 4. Pemetrexed combined with platinum-based chemotherapy for patients who have not progressed in RECIST after 4-6 cycles; 5. Aged 18 years old or above, male or female; 6. ECOG PS: 0-3 points; 7. The expected survival period is greater than or equal to 12 weeks; 8. The main organ function levels meet the following criteria: The main organs function normally, meet following criteria: (1) Blood routine examination standards should be consistent with: ANC=1.5×10^9/L, PLT=75×10^9/L, Hb=90g/L (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli); (2) Biochemical examination should meet the following criteria: TBIL<1.5×ULN, ALT, AST<2.5×ULN patients with liver metastasis can <5×ULN, BUN and Cr=1×ULN or endogenous creatinine clearance =50ml/min ( Cockcroft-Gault formula); 9. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last to test drugs after 8 weeks, using appropriate methods of contraception; 10. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma (including adenosquamous carcinoma), small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer); 2. The patient's genetic test is EGFR-sensitive mutation or positive for ALK fusion gene, and patients who have not received targeted therapy; 3. Symptomatic brain metastasis, cancerous meningitis (patients with brain metastasis who have completed treatment and stable symptoms for 21 days before enrollment,those patients can be enrolled, but need to be confirmed by brain MRI, CT or venography to have no cerebral hemorrhage symptoms); 4. Imaging (CT or MRI) shows that the tumor lesion is = 5 mm from the large vessel, or there is a central tumor that invades the local large blood vessel; or that there is a significant pulmonary cavity or necrotizing tumor; 5. People with high blood pressure who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 6. myocardial ischemia with above grade II or myocardial infarction, arrhythmia,(including QTc interval male = 450 ms, female = 470 ms); according to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 9. There is obvious coughing blood in the 2 months before enrollment, or daily hemoptysis up to 2.5ml or more; 10. Significant clinically bleeding symptoms or a clear tendency to hemorrhage within 3 months prior to enrollment; 11. Events of arterial/venous thrombosis occurring within 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 12. Known hereditary or acquired bleeding and thrombophilia (eg hemophilia patients, coagulopathy, thrombocytopenia, hypersplenism, etc.); 13. Long-term unhealed wounds or fractures; 14. Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks of enrollment; 15. A variety of factors affecting oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, significantly affecting the use and absorption of drugs); 16. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment; 17. Urine routinely showed urinary protein = ++ or confirmed 24-hour urine protein quantitation > 1.0 g; 18. Patients with a history of psychotropic substance abuse who cannot be cured or who have mental disorders; 19. Participated in other clinical trials of anti-tumor drugs within 4 weeks before enrollment; 20. Previous or concurrent with other unhealed malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer; 21. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; 22. The investigator determines other conditions that may affect the conduct of the clinical study and the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective remission rate ;Disease control rate ;Quality of Life; | — |
Countries
China
Contacts
Public ContactBo Zhu
Xinqiao Hospital, Army Medical University
Outcome results
None listed