Lung cancer
Conditions
Interventions
Experiment group:Amitinib in combination with bevacizumab
Sponsors
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Written informed consent has been obtained from the patient or his/her legal representative; 2) Patients aged >= 18 years, male or female; 3) Non-small cell lung cancer confirmed by histological or cytological pathology; 4) Genetic testing confirmed positive EGFR classic mutation; 5) New brain metastases due to disease progression after previous EGFR-TKI anti-tumor treatment; or progression of existing brain metastases; 6) Previous radiotherapy or surgery targeting the central nervous system was allowed; 7) Patients with CNS symptoms or signs were allowed to be included, but these symptoms or signs were not life-threatening; 8) PS score 12 weeks; 10) Males of reproductive potential or females of pregnancy potential must use highly effective contraceptive methods (such as oral contraceptives, intrauterine contraceptive devices, sexual abstinence, or barrier contraceptive methods combined with spermicides) during the trial and continue to use contraceptive methods for 12 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1) Currently combined with other tumors except NSCLC; 2) Suffering from other malignant tumors or having a history of other malignant tumors in the past 5 years, except for basal cell carcinoma of the skin, carcinoma in situ of the cervix and ductal carcinoma in situ of the breast that have been effectively controlled; 3) the presence of nerve compression symptoms or meningeal metastasis; 4) The patient has severe gastrointestinal diseases that affect drug administration and absorption, including but not limited to peptic ulcer, inflammatory bowel disease, etc. 5) Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, and active bleeding, any disease that the investigator believes is not conducive to the patient's participation in the study or undermines compliance with the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV); 6) history of interstitial lung disease, drug-induced interstitial lung disease, previous history of radiation pneumonitis requiring steroid treatment, or any evidence of active interstitial lung disease; 7) The presence of significant arrhythmia (such as QT interval prolongation > 500ms) or heart failure (left ventricular ejection fraction < 50%) 8) Pregnant or breastfeeding women; 9) patients who received live vaccination within 4 weeks before the start of treatment; 10) Patients who are currently participating in other clinical studies or have participated in other clinical studies within 4 weeks;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom improvement rate; | — |
Countries
China
Contacts
Public ContactQiming Wang
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Outcome results
None listed