Lung Cancer
Conditions
Interventions
Test group:Endostatin combined with radiotherapy, envolizumab immunotherapy
Sponsors
Beijing Chest Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent; 2. age =18 years old, male or female; 3. Patients with advanced, metastatic or recurrent non-small cell lung cancer proven histologically or cytologically to be inoperable; 4. according to the solid tumor efficacy evaluation standard version 1.1, there are measurable lesions; 5. ECOG (American Eastern Cancer Collaboration) Physical status score: 0~3; 6. Patients with underlying diseases have stable disease control; 7. The expected survival period assessed by doctors is more than 3 months; 8. the main organ function is good, that is, meet the following standards: A. Routine blood examination (no transfusion within 14 days prior to screening, no use of granulocyte colony stimulating factor, no use of drug correction) : a) Neutrophils =1.5 ×10^9 / L; b) Platelet =100 ×10^9 / L; c) Hemoglobin =90 g/L; d) White blood cells =3.0×10^9 / L B. Blood biochemical examination (no blood transfusion within 14 days prior to screening) : e) Total bilirubin < 1.5×ULN; f) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5×ULN (for patients with liver metastasis, it can be enlarged to < 5×ULN); g) Serum creatinine value =1.5×ULN or creatinine clearance =50 ml/min (Cockcroft-Gault formula); C. coagulation function: INR < 1.5×ULN and APTT < 1.5×ULN (did not receive anticoagulation therapy); D. urine routine examination: urine protein < ++ or 24-hour urine protein quantity =1g; E. Cardiac Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) =50%; 9. compliance is good, the family agreed to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1. All patients with or without brain metastases should be evaluated by brain MRI, CT or venography. Symptoms of cerebral hemorrhage cannot be excluded; 2. Patients with imaging evidence of tumor invasion of large blood vessels (tumor has completely approached, circumvented, or invaded the lumen of large blood vessels (such as pulmonary artery or superior vena cava); 3. patients with hypertension and antihypertensive drug treatment of blood pressure is not satisfactory control (sitting systolic blood pressure >150 mmHg, or diastolic blood pressure >100 mmHg), hypertensive crisis or hypertensive encephalopathy in the past; (4) have heart disease or clinical symptoms that are not well controlled, such as ?NYHA grade II or above cardiac insufficiency; ? Unstable angina pectoris; ? Myocardial infarction occurred within 1 year; ? Supraventricular or ventricular arrhythmias require treatment or intervention; 5. Patients with unhealed wounds, active gastric ulcers or fractures; 6. Patients diagnosed with esophagotracheal fistula; 7, known to have inherited bleeding tendencies or coagulation disorders; 8. Patients who received full dose anticoagulant or thrombolytic therapy within 10 days prior to randomization, or NSaids with platelet inhibition within 10 days prior to randomization (except prophylactic low-dose aspirin (=325mg/ day)); 9. Patients with a history of major surgery (including open chest biopsy), major trauma (such as fracture), or who may undergo surgery during the course of this trial within 28 days prior to randomization; 10. Two or more degrees of hemoptysis occurred in the 3 months before randomization (a single hemoptysis volume =1/2 TSP (2.5ml)); 11. For patients with thrombosis in the 6 months before randomization, hyperarterial/venous thrombosis events occurred within the 1 year before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 12. Patients with severe vascular lesions (including aneurysms or arterial thrombosis requiring surgical treatment) within 6 months before randomization; 13, pregnancy (serum pregnancy test positive), planning pregnancy and breastfeeding women; 14. Other circumstances determined by the investigator to be unsuitable for participation in this study; 15, urine routine suggests urine protein = ++, or confirmed 24 hours of urine protein =1.0g; 16, have significant influence on oral drug absorption factors, such as inability to swallow, chronic diarrhea and intestinal obstruction; 17, Clinically significant hemoptysis within 3 months (more than 1 teaspoon of hemoptysis per day); Or clinically significant bleeding symptoms or definite bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood ++ or above at baseline, or vasculitis;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactCuimeng Tian
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed