A prospEctive observatioNal study evaluating profiling of T cell binding to anti-PD-1 antibody using peripHeral blood as signAture for tumor respoNse during ramuCirumab and docEtaxel afteR anti-PD-1 antibody - ENHANCER study

Graduate School of Medicine, Osaka University0 个研究点目标入组 21 人开始时间: 2023年3月3日最近更新: 2023年10月17日

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•1. Patients who have received ipilimumab as a previous therapy 2. Patients receiving more than steroids equivalent to 10 mg of prednisone per day 3. Patients who are judged by the attending physician to be ineligible for this study Obvious invasion into the main bronchus Obvious intratumor cavitation on imaging Obvious involvement of major thoracic vessels with risk of major hemorrhage Hemoptysis of more than 5 ml within 2 months (blood sputum is acceptable) History of gastrointestinal perforation/fistula or risk factors for perforation/fistula within 6 months Grade 3-4 gastrointestinal bleeding within 3 months Major surgery within 1 month or evidence of severe unhealed wound or minor surgery/subcutaneous venous access device placement within 7 days or bone fractures within 28 days Hypertension completely uncontrolled by medication (systolic >150 mmHg, diastolic >90) Presence of severe (Child-Pugh B or higher, hepatic encephalopathy) cirrhosis or clinically meaningful ascites resulting from cirrhosis Deep vein thrombosis, pulmonary embolism, or other thrombosis within 3 months Arterial thromboembolic event such as myocardial infarction, transient ischemic attack, cerebrovascular disease, or unstable angina within 6 months Receipt of chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents (325mg daily aspirin is permitted) Reproductive precautions; the patient is pregnant or breast-feeding 4. Patient is unable to give his/her consent

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