lung cancer
Conditions
Interventions
experimental group:Anlotinib+TKI
Sponsors
Affiliated Tumor Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patients voluntarily participated in the study and signed informed consent; 2) the late stage (stage IIIB/IV) non-small cell lung cancer diagnosed by pathology has measurable lesions; 3) Patients with EGFR gene-sensitive mutations who received first-generation EGFR-TKI therapy were assessed by imaging for slow progression; 4) ddPCR method was used to detect T790M mutation negative patients; 5) gene detection of ALK gene test negative results; 6) Aged 18-75 years old; ECOG PS score 0~2; and the expected survival is more than March; 7) no major abnormalities in organ function.
Exclusion criteria
Exclusion criteria: 1) patients who had previously used the compound of hydrochloride and atlotinib; 2) small cell lung cancer (including small cell lung cancer and non-small cell lung cancer); 3) patients who were positive for EGFR and ALK mutations but were not treated with targeted drugs; 4) Central, caval lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis (>50 ml / day); 5) Other malignant tumors, including cervical carcinoma in situ, skin cancer of non-melanoma and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)], have been or are currently present within 5 years; 6) Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of mitomycin within six weeks prior to trial medication) is planned within the first four weeks of the grouping or during this study; 7) Unremitted toxicity above CTCAE1 level due to any previous treatment, excluding hair loss and neurotoxicity below grade 2 due to oxaliplatin; 8) those with multiple factors affecting oral medication (e.g. dysphagia, chronic diarrhea, intestinal obstruction, etc.); 9) with pleural effusion or ascites, causing respiratory syndrome (more than CTC AE 2 grade dyspnea); 10) patients with brain metastases with symptoms or symptoms less than 2 months; 11) any patient with severe and / or not controlled diseases; 12) 28 days before the group received major surgical treatment, open biopsy or obvious traumatic injury; 13) Imaging findings showed that the tumor had invaded the perivascular space of the important vessels or that the tumor was highly likely to invade the important vessels during the follow-up study, leading to fatal bleeding. 14) Patients with any signs or history of bleeding, regardless of severity, had unhealed wounds, ulcers or fractures in patients with any bleeding or bleeding event (>CTCAE 3) within the first four weeks of the grouping; 15) There were arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 16) having a history of psychotropic substance abuse and unable to quit or have mental disorders; 17) participated in other clinical trials of antineoplastic drugs within four weeks; 18) Patients with concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study, according to the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CT; | — |
Countries
China
Contacts
Public ContactLiu Chunling
Affiliated Tumor Hospital of Xinjiang Medical University
Outcome results
None listed