Non-small cell lung cancer
Conditions
Interventions
Case series:Oral Anlotinib 12mg/qd, Stop using for one week after two consecutive weeks,Q3W, until disease progression
Sponsors
Xingtai People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Newly diagnosed patients with non-small cell lung cancer (NSCLC) confirmed by cytology or histology; according to the 2017 new UICC lung cancer staging standard (8th edition) diagnosed as stage IIIB, IIIC or IV, and no known EGFR sensitive mutations Patients with ALK mutations (Note: IIIb and IIIc must be patients who cannot undergo radical surgery and have not received concurrent radiotherapy and chemotherapy); 2) First-line patients who have received platinum-containing dual-drug combined with bevacizumab for 4-6 cycles of remission or stable disease: According to RECIST1.1 standard, it is judged as complete remission (CR), partial remission (PR) or stable (SD); 3) Patients must be enrolled =3 months; 7) According to the RECIST1.1 standard, before the first-line chemotherapy, the patient has at least one imaging (CT, MRI) measurable or evaluable lesion; the lesion has not been treated with radiation within 3 months. The longest diameter of the target lesion must be greater than or equal to 10mm (the short axis of the lymph node is greater than or equal to 15mm to be the target lesion); 8) Women: For all women who may become pregnant, a pregnancy test must be taken within 7 days before the start of treatment, or a medically approved method of contraception during the treatment and within 3 months after the end; the serum or urine pregnancy test must be negative, Must be non-lactating; male: use contraceptive measures during surgical sterilization or treatment and within 3 months after the end; 9) The functional level of organs must meet the following requirements: Blood routine: ANC>=1.5x10^9/L; PLT>=100x10^9/L; Hb>=90g/L Blood biochemistry: TBIL=50ml/min; Heart color Doppler ultrasound: LVEF>=50%; 12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method <450ms for males and <470ms for females; 10) The subject has the ability to understand and sign the informed consent form, and must sign the informed consent form before any screening assessment.
Exclusion criteria
Exclusion criteria: 1) Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer); 2) Lung squamous cell carcinoma that invades the hilar, or non-small cell lung cancer with hemoptysis, including pulmonary hemorrhage/hemoptysis (>1/2 teaspoon of bright red blood) within 3 months; or significant clinically significant bleeding symptoms or Have a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above, or suffering from vasculitis, etc. 3) The patient is participating in other clinical studies or is less than 4 weeks from the end of the previous clinical study; 4) Patients with acute intracranial, subacute cerebral infarction, acute intracranial lesions, and subacute hemorrhage; 5) The unresolved acute toxicity period that is higher than CTC AE (5.0) level 2 or more caused by any previous treatment; 6) Those who have multiple factors that affect oral medications (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 7) Advanced patients who have severe symptoms, have spread to the internal organs, and are at risk of life-threatening complications in the short term; 8) There are other life-threatening patients with severe and/or uncontrolled diseases; 9) Patients who have received major surgical treatment, open biopsy or obvious traumatic injury within 1 month before enrollment and have not healed; 10) Regardless of the severity, patients with any signs of bleeding or medical history; unhealed wounds, gastrointestinal ulcers or fractures; 11) Those who have experienced arterial/venous thrombosis, deep vein thrombosis and pulmonary embolism within 6 months; 12) Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 13) According to the judgment of the investigator, there are persons with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactJun Guo
Xingtai People's Hospital
Outcome results
None listed