Lung adenocarcinoma without driver gene mutation
Conditions
Interventions
Sponsors
The People's Hospital of Tongliang District, Chongqing
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed lung adenocarcinoma without driver gene mutation; 2. Before the enrollment, provide detectable specimens (tissue or chest and ascites specimens) for genotypic testing, no EGFR, ALK and other driving gene mutations; or no EGFR, ALK and other driving gene mutation detection reports; 3. No one or two of docetaxel and apatinib were used in the pre-treatment of the patient; 4. Have at least one evaluable lesion: tumor lesion CT scan long diameter = 10mm, lymph node lesion CT scan short diameter = 15mm, scan layer thickness is not more than 5mm, measurable lesions have not received radiotherapy, freezing and other local treatment (refer to RECIST 1.1); 5. Age 18 years old or above, male or female; ECOG PS: 0-2 points; 6. Estimated survival time = 12 weeks; 7. The main organ function levels meet the following criteria: 1) Blood routine examination criteria should be consistent with: ANC=1.5×109/L, PLT=80×109/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, ALT, AST can be <5×ULN, BUN and Cr=1×ULN or endogenous creatinine clearance = 50ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative and willing to use appropriate during the trial and 8 weeks after the last administration of the test drug. Method of contraception. 9. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.
Exclusion criteria
Exclusion criteria: 1. Lung squamous cell carcinoma (including lung cancer with squamous cell carcinoma); large cell lung cancer (including large cell carcinoma and non-large cell mixed lung cancer); small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer); 2. Symptomatic brain metastasis, cancerous meningitis (patients with brain metastasis who have completed treatment and stable symptoms 21 days before enrollment can be enrolled, but need to be confirmed by brain MRI, CT or venography to have no cerebral hemorrhage symptoms ); 3. 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); 4. Imaging (CT or MRI) shows that the tumor lesion is = 5 mm from the large blood vessel, or there is a central tumor invading the local large blood vessel, or there is a significant pulmonary cavity or necrotizing tumor; 5. Arrhythmia with grade II or higher myocardial ischemia or myocardial infarction, poor control; according to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%; 6. abnormal blood coagulation, or known hereditary or acquired bleeding tendency and thrombotic tendency; 7. Have undergone major surgery or severe traumatic injury, fracture or ulcer within 4 weeks of enrollment; 8. Patients who received a potent CYP3A4 inhibitor within 7 days prior to randomization or who received a potent CYP3A4 inducer within 12 days prior to the study; 9. 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); 10. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment; 11. Urine routine indicates urinary protein = ++, or confirmed 24-hour urine protein = 1.0 g; 12. Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 13. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; 14. 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;Disease control rate;Objective remission rate;Quality of Life; | — |
Contacts
Public ContactXiaoping Li
The People's Hospital of Tongliang District, Chongqing
Outcome results
None listed