a trial of anlotinib combined with concurrent chemoradiotherapy in patients with unresectable stage iii non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase i/ii exploratory study to evaluate the efficacy and safety of anlotinib combined with concurrent chemoradiotherapy in the treatment of surgically unresectable stage iii non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * 1. the patients volunteered to participate in this study and signed the informed consent; * 2. locally advanced (iiia/iiic) non-small cell lung cancer patients diagnosed by pathology as newly diagnosed unresectable, inoperable or refused surgery (difficult patients should be evaluated by thoracic multidisciplinary assessment for potential enrollment); . * 3. ages 18-75, regardless of gender; * 4. ecog score: 0-1; * 5. expected survival over 3 months; * 6. function of major organs within 7 days prior to treatment meets the following criteria: a. standard of blood routine examination (without blood transfusion within 14 days) : i. hemoglobin (hb) ≥100 g/l; ii. wbc ≥3.0×109/l; iii. platelet (plt) ≥100×109/l. b. biochemical examination shall meet the following standards: i. total bilirubin (tbil) ≤1.5 times the upper limit of normal value (uln); ii. ast≤2.5×uln of alanine aminotransferase (alt) and aspartate aminotransferase (aspartate), if accompanied by liver metastasis, alt and ast≤5×uln; iii. serum creatinine (cr) ≤1.5×uln or creatinine clearance rate (ccr)≥60ml/min; c. doppler ultrasound evaluation: left ventricular ejection fraction (lvef) ≥ lower normal limit (50%); d. pulmonary function assessment: fev1≥1.45 l/s. * 7. patients of childbearing age (including female and female partners of male patients) must take effective birth control measures exclusion criteria: * 1. patients who have previously used anlotinib hydrochloride capsules; * 2. small cell lung cancer (including mixed small cell and non-small cell cancers); * 3. lung squamous cell carcinoma with empty cavity, or non-small cell lung cancer with hemoptysis (\> 20ml/day); * 4. patients with other malignant tumors other than nsclc within 5 years before the start of treatment in this study (except those with simple surgical resection and disease-free survival for at least 5 consecutive years, cured cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumor); * 5. systemic antitumor therapy, including cytotoxic therapy, signal transduction inhibitors and immunotherapy, is planned within 4 weeks before enrollment or during the medication period of this study.in addition to thymosin, lentinan and other immunomodulator treatment. * 6. unmitigated toxicity due to any previous treatment above ctc ae level 1, excluding hair loss; * 7. patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); * 8. accompanied by pleural effusion or ascites, causing respiratory syndrome (≥ctc ae level 2 dyspnea); * 9. patients with any severe and/or uncontrolled disease, including: a) patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmhg, diastolic blood pressure ≥100 mmhg); b) having grade i or above myocardial ischemia or infarction, arrhythmia (including qtc ≥480ms), and grade 2 or above congestive heart failure (new york heart association (nyha) classification); c) active or uncontrolled severe infection (≥ctc ae level 2 infection); d) antiviral treatment for cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; e) renal failure requires hemodialysis or peritoneal dialysis; f) a history of immunodeficiency, including hiv positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; g) poor control of diabetes mellitus (fbg) \> 10mmol/l; h) urine routine indicated urinary protein ≥++, and confirmed 24-hour quantitative urinary protein \> 1.0g; i) patients with epileptic seizures requiring treatment; j) patients with gastric ulcer * 10. receive major surgical treatment, open biopsy or significant traumatic injury within 28 days before grouping; * 11. patients whose tumors have invaded important blood vessels according to imaging findings or whose tumors are likely to invade important blood vessels during the follow-up study according to the judgment of the researchers, resulting in fatal massive hemorrhage; * 12. patients with any physical signs or history of bleeding, regardless of severity;patients with any bleeding or bleeding event ≥ctcae level 3 within 4 weeks prior to enrollment have unhealed wounds, ulcers or fractures; * 13. occurrence of arterial/venous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks), deep venous thrombosis and pulmonary embolism within 6 months; * 14. persons with a history of abuse of psychotropic substances and who cannot be cured or have mental disorders; * 15. pregnant and lactating women; * 16. participated in other clinical trials of anti-tumor drugs within 4 weeks; * 17. the researcher considered that there were other conditions that were not suitable for inclusion.