KCT0006739尚未招募未知
Efficacy and Safety of Sorafenib in Previously treated Advanced Hepatocellular Carcinoma: SOPT study
ational Cancer Center0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 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 Study
入排标准
- 年龄范围
- 20?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •(1) Signed written informed consent
- •(2) Age ? 20
- •(3) Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center
- •(4) Locally advanced unresectable or metastatic disease not amenable to curative surgical and/or locoregional therapies
- •(5) Intolerant to or progressed on at least 1 prior systemic treatment for HCC
- •(6) Having at least one measurable target lesion (per RECIST v1.1)
- •- Patients who received prior local therapy (e.g., radiofrequency ablation, transarterial chemoembolization, transarterial embolization, radiation therapy etc.) are eligible provided that other target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST 1.1.
- •(7) Child-Pugh class A or B7
- •(8) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
- •(9) Life expectancy of at least 16 weeks
- •(10) Adequate hematologic and hepatic function (should be obtained within 14 days prior to initiation of study treatment):
- •?Hemoglobin = 8.0 g/dL
- •?Absolute neutrophil count (ANC) = 1,000/mm3
- •?Platelet count = 50,000/µL
- •?Total bilirubin < 3.0 mg/dL
- •?Serum albumin > 2.8 g/dL
- •?Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 × upper limit of normal
- •?Prothrombin time in INR = 1.8 × upper limit of normal
- •?Serum creatinine = 2.0 mg/dL
- •(11)Women of childbearing potential and men must agree to use highly efficient contraception since signing of the IC form until at least 5 months (women) and 7 months (men) after the last study drug administration.
排除标准
- •(1) Fibrolamellar carcinoma or sarcomatoid carcinoma
- •(2) Having active brain metastasis or leptomeningeal metastasis
- •(3) Moderate to severe or intractable ascites
- •(4) Presence of hepatic encephalopathy
- •(5) Presence of active bacterial infection
- •(6) Uncontrolled severe medical comorbidity
- •(7) Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient’s malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years)
- •(8) Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study
研究者
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