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 人开始时间: 2022年1月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
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).
- •6.Child Pugh score of 5-6 within 14 days prior to enrollment
- •7.No other active malignancies
- •8.A patient's written informed consent (IC) has been obtained after sufficient explanation of study given to the patient.
- •9. Hepatocellular carcinoma tumor conditions are classified as A, B, C, D, or E. *1 Unresectable hepatocellular carcinoma.
- •A) [Intrahepatic vascular invasion] Intrahepatic tumors are classified as Vv2-3, Vp2-4, and B2-4.
- •No extrahepatic tumor.
- •Vv2: Invasion/tumor thrombus is observed in either the right middle and left hepatic vein main trunks, the inferior right hepatic vein, or the short hepatic vein.
- •Vv3: Invasion and tumour thrombus in the inferior vena cava.
- •Vp2: Invasion and tumour thrombus in the secondary branch of the portal vein.
- •Vp3: Invasion and tumour thrombus in the primary branch of the portal vein.
- •Vp4: Invasion and tumour thrombus are observed in the main trunk of the portal vein and the contralateral portal vein branches.
- •B2: Invasion and tumor thrombus in the secondary branch of the bile duct.
- •B3: Invasion and tumor thrombus in the primary branch of the bile duct.
- •B4: Invasion and tumor thrombus in the common bile duct.
- •B) [Synchronous extrahepatic metastases] Intrahepatic tumors are resectable without gross vascular invasion. Extrahepatic tumors such as distant organ metastases, peritoneal metastases, lymph node metastases, and tumor dissemination along the puncture route are present. *2
- •C) [Intrahepatic vascular invasion and synchronous extrahepatic metastasis]. Intrahepatic tumor is Vv2-3, Vp2-4, and B2-4, and diagnosed as synchronous extrahepatic metastasis*2
- •D) [ Macroscopic residual tumor] Applied when complete resection of intrahepatic tumor was difficult but therapeutically meaningful surgical resection was performed.*3
- •E) [Metachronous extrahepatic metastases] No or controllable intrahepatic tumor. Diagnosed with extrahepatic metastasis *4.
- •*1 The oncological condition of A-E is poor in prognosis and oncologically unresectable. It is also classified as unresectable according to the BCLC staging system frequently used worldwide (Appendix 3). In the past, surgical resection for hepatocellular carcinoma with extrahepatic metastasis and vascular invasion has been performed only in some centers with a large number of resected cases of hepatocellular carcinoma, but the long-term prognosis is poorer compared with cases with
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).
- •10.Critical cardiovascular disease (New York Heart Association [NYHA] Class II or higher heart disease, myocardial infarction), unstable arrhythmia or unstable angina in the 90 days prior to enrollment.
- •11.Pregnant, breastfeeding, positive in pregnancy test (pregnancy tests performed in menstruating women within the past year), women and men unwilling to contraceptive during the study period.
- •12. Has clinically uncontrolled pleural effusion, pericardial effusion or ascites.
- •13.Has complications of hepatic encephalopathy
- •14.Has serious complications as listed below
- •Uncontrolled hypertension with or without antihypertensive medication
- •Severe infections (e.g., hospitalization for complications of infection, bacteremia, severe pneumonia) occurred within 28 days before enrollment. Excluding hepatitis B virus (HBV) and hepatitis C virus (HCV).
- •Currently receiving hemodialysis due to renal failure or has a serious mental illness or allergic reaction to contrast medium interfering with angiography, e
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