non-small cell lung cancer
Conditions
Interventions
trial group:Amlotinib hydrochloride combined with arterial chemoembolization
Sponsors
Department of Interventional medicine, the First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be enrolled in this study, patients must meet all the following inclusion criteria: 1. The patient is male or female, aged 18-75 years. 2. ECOG physical condition score 0-2;Expected survival >= 12 weeks. 3. Non-small cell lung cancer (NSCLC) was pathologically confirmed;Tumor stage: IA - VI period. 4. IA -III A reluctance to accept surgery and cannot accept the surgical treatment of patients; III phase B ~ IV refused to systemic chemotherapy or chemotherapy can't tolerance or received at least two kinds of systemic disease progression of patients after chemotherapy regimens. 5. Provide detectable specimens (tissue or cancerous pleural effusion) for genetic testing and test negative for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) fusion gene, or test positive for drug resistance or intolerance after treatment with relevant targeted drugs. 6. With measurable lesions, at least one measurable lesion (helical CT scan >= 10 mm, scanning thickness no greater than 5mm) (RECIST version 1.1). 7. The functions of vital organs meet the following requirements: A. Absolute count of neutrophils (ANC) >= 1.5*10^9/L; B. Platelet >= 75*10^9/L; C. Hemoglobin >= 8g/dL; D. Serum albumin >= 2.8g/dL; E. Bilirubin = 50mL/min (Cockcroft-Gault, annex iii); G. Normal thyroid function; H. Full cardiac function, left ventricular ejection fraction (LVEF)>50% by two-dimensional echocardiography. 8. No history of serious drug allergy. 9. Women of childbearing age must already have access to reliable contraceptives or undergo pregnancy tests prior to enrolment. 10. Subjects volunteered to join the study.Informed consent was signed with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications to antinib hydrochloride: active bleeding, ulcer or fracture, intestinal perforation and obstruction, high blood pressure beyond drug control within 30 days after major surgery, grade III-IV cardiac insufficiency, severe hepatic and renal dysfunction, and thyroid dysfunction. 2. Central type, cavity lung squamous cell carcinoma, or accompanied by hemoptysis (>50ml/d); Imaging shows that the tumor invades important blood vessels, or that the tumor is likely to invade important blood vessels during the follow-up study, leading to fatal hemorrhage. 3. Tumor accumulates respiratory tract, and airway stents cannot relieve respiratory distress. 4. Abnormal coagulation function (INR>1.5 or PT>ULN+4 seconds or APTT > 1.5uln), having a high blood tendency or receiving thrombolysis or anticoagulant therapy;Arterial/venous thrombotic events (e.g., cerebrovascular accident, deep vein thrombosis, and pulmonary embolism) occurred within 6 months. 5. 3/4 grade transaminase or total bilirubin increase;Urine routine suggested that urine protein >= ++, or confirmed that 24-hour urine protein amount >= 1.0g. 6. Other malignancies were diagnosed within 5 years prior to the first use of the study drug, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or cervical and/or breast cancer in situ which were effectively removed. 7. Patients with central nervous system metastases or known brain metastases. 8. Women who are pregnant or breastfeeding. 9. Patients prone to infection and poor blood sugar control. 10. Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe pulmonary function impairment, etc. 11. Systemic failure, estimated survival < 3 months. 12. The investigator determines other conditions that may influence the conduct of the clinical study and the determination of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Time to disease progression;Duration of remission;Objective mitigation rate;Disease control rate;Complete response;Some relief; | — |
Countries
China
Contacts
Public Contactxuhua Duan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed