JPRN-jRCTs051210148
招募中
未知
Resection of initially unresectable hepatocellular carcinoma with atezolizumab combined with bevacizumab - RACB
Hatano Etsuro0 个研究点目标入组 50 人2022年1月7日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Hepatocellular Carcinoma
- 发起方
- Hatano Etsuro
- 入组人数
- 50
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Diagnosed with hepatocellular carcinoma and no prior medical therapy (sorafenib, lenvatinib and immunotherapy) for hepatocellular carcinoma
- •2\.Have at least one target lesion based on RECISTver1\.1 criteria
- •3\.Age 20 years or older
- •4\.Eastern Cooperative Oncology Group Performance Status (PS) 0\-1
- •5\.Adequate organ function
- •If more than one test result is present within the study period, the most recent one to enrollment should be employed, and no blood transfusion and administration of hematopoietic factor products have been performed within 30 days before the test day for measurement prior to enrollment.
- •WBC \>\=3000/mm3, neutrophil count \>\=1500/mm3, Hb \>\=8\.5g/dL, platelet count \>\=60,000/mm3, total bilirubin \<\=3\.0 mg/dL, serum albumin \>\=2\.8g/dL, AST (GOT), ALT (GPT) \<\=5 times the upper limit of each medical institution (excluding cases associated with cancer)
- •Serum creatinine \<\=1\.5 times the upper limit of each medical institution
- •Urine protein\<\= 2\+
- •Urine protein/creatinine ratio \<2\.0 at any time when urine protein is \>\=3\+ (urine protein \< 2\.0g in case of 24\-hour urine collection).
排除标准
- •1\. Currently receiving full doses of oral or parenteral anticoagulants or thrombolytics intended for treatment (not for prophylaxis) or has received them within 10 days prior to enrollment\*.
- •\*Examples: Current use of aspirin (\>325 mg/day), dipyridamole, ticlopidine, clopidogrel, or cilostazol, or used within 10 days before enrollment.
- •2\. Have untreated or not adequately treated esophageal varices and/or varices with or at high risk of bleeding, or a history of bleeding due to esophageal varices and/or varices within 180 days prior to enrollment. (All varices of any size should be examined by esophagogastroduodenoscopy (EGD) and treated prophylactically according to the standard therapy of the participating medical institutions before enrollment. If the presence of varices is ruled out by EGD within 180 days before enrollment, repeat procedures will not be required.)
- •3\. Had thrombosis and/or embolism within 180 days before enrollment.
- •4\. Has undergone major surgical procedures (thoracotomy, open surgery, thoracoscopic surgery, laparoscopic surgery, etc.) within 28 days before enrollment. Patients have undergone open wound biopsy, or suture procedures for major trauma, or will receive major surgical procedures (thoracotomy, open surgery) during the study period.
- •5\. Has received systemic immunostimulatory agents (e.g., interferon, interleukin\-2 \[IL\-2]) within 180 days prior to enrollment.
- •6\. Has received systemic immunosuppressants (e.g., corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, tumor necrosis factor \[TNF]\-alpha inhibitors) within 14 days before enrollment or expected to receive systemic immunosuppressants during the study period. Except for patients treated with mineralocorticoids (such as fludrocortisone) or corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma.
- •7\.History and complications of autoimmune disease within 180 days prior to enrollment
- •8\. History of active double cancer or malignancy \* (synchronous double cancer and metachronous double cancer with disease\-free interval \< 3 years). \* Excluding early\-stage cancers with low risk of recurrence that were treated appropriately with radical treatment, such as cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumor, early esophageal cancer, early gastric cancer, and early colorectal cancer.
- •9\. Currently participating in another study of unapproved drugs or a study requiring intervention (including a follow\-up period).
结局指标
主要结局
未指定
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