JPRN-jRCT2051230057招募中3 期
A Phase IIIb Single Arm, Open-label, Multicentre Study of Durvalumab and Tremelimumab as First Line Treatment in Participants with Advanced Hepatocellular Carcinoma - SIERRA
Kim Young Hak0 个研究点目标入组 25 人开始时间: 2023年6月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Confirmed HCC based on histopathological findings from tumour tissue
- •-Must not have received prior systemic therapy for HCC
- •-Minimum life expectancy of 12 weeks
- •-At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as >= 10 mm in the longest diameter with CT or MRI, and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines
- •-Must not be eligible for LRT for unresectable HCC.
- •-Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy LRT) or stage C
- •-Child-Pugh Score classification on liver disease and WHO/ECOG PS at enrolment complying one of the following:
- •(a)Child-Pugh score B7 or B8 with a WHO/ECOG PS of 0-1 at enrolment, without main trunk portal vein thrombosis.
- •(b)Child-Pugh class A with a WHO/ECOG PS of 2 at enrolment, without main trunk portal vein thrombosis (ie, ECOG PS 2 participants with main portal vein tumour thrombosis are excluded from this study).
- •(c)Child-Pugh class A with WHO/ECOG PS of 0-1 at enrolment and evidence of chronic main trunk portal vein thrombosis
- •-Participants with hepatitis B virus (HBV) infection must be treated with antiviral therapy prior to enrolment.
- •-Participants with hepatitis C virus (HCV) infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV RNA or anti-HCV upon enrolment
- •-Adequate organ and bone marrow function
- •-Negative pregnancy test (serum) for women of childbearing potential.
- •- Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control
- •-Male and Female participants and their partners must use an acceptable method of contraception.
- •-Body weight >30 kg
排除标准
- •-Any evidence of acute or uncontrolled diseases or history of allogeneic organ transplant
- •-Refractory nausea and vomiting, chronic gastrointestinal (GI) disease, inability to swallow a formulated product, or previous significant bowel resection
- •-History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia
- •-History of another primary malignancy except for:
- •a) Malignancy treated with curative intent with no known active disease >= 5 years before the first dose of study intervention and of low potential risk for recurrence, or
- •b) Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has undergone potentially curative therapy, or
- •c) Adequately treated carcinoma in situ without evidence of disease
- •-Persistent toxicities (Common Terminology Criteria for Adverse
- •Events [CTCAE] Grade > 2) caused by previous anticancer therapy
- •-Active or prior documented autoimmune or inflammatory disorders
- •-History of active primary immunodeficiency
- •-History of leptomeningeal carcinomatosis
- •-History of hepatic encephalopathy within the past 12 months or requirement for medications to prevent or control encephalopathy
- •-Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within the past 6 months.
- •-Evidence of acute main trunk portal vein thrombosis
- •-History of previous, or current, brain metastases or spinal cord compression
- •-Known fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •- Clinically meaningful ascites
- •- Participants co-infected with HBV and HCV or co-infected with HBV and hepatitis D virus (HDV)
- •-Known to have tested positive for human immunodeficiency virus (HIV) or active tuberculosis infection
- •-Prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines
- •-Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab
研究者
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