2024-515127-11-00招募中2 期
A randomized open-label phase II study on the effect of durvalumab and tremelimumab combined with personalized SIRT (p-SIRT), standard-dose SIRT (sd-SIRT) or immunotherapy followed by on-demand loco-regional SIRT (od-SIRT) in non-resectable hepatocellular carcinoma (HCC) patients
Klinikum der Universitaet Muenchen AöR6 个研究点 分布在 2 个国家目标入组 77 人开始时间: 2024年8月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 77
- 试验地点
- 6
- 主要终点
- Objective Response Rate (ORR compared to SIRT historical control)
研究概览
简要总结
To assess the objective response rate in non-resectable HCC patients employing a treatment strategy with first-line systemic treatment in combination with SIRT compared to standard SIRT (historical control)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histological diagnosis of HCC
- •Life expectancy of at least 12 weeks
- •Disease which is not amenable to curative surgical or ablation treatment but eligible for locoregional treatment including portal vein invasion Vp1-
- •Patients who are candidates for liver transplantation list are eligible at the discretion of the local investigator.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Preserved liver function, as defined by a Child-Pugh score A and B7
排除标准
- •Diffuse HCC or presence of vascular invasion in the portal vein main stem (Vp4) or extrahepatic spread (including extrahepatic lymph node affection or metastasis) or more than 7 lesions or at least one lesion ≥ 10 cm
- •Major gastrointestinal bleeding within 4 weeks prior to inclusion
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Decompensated liver function as defined by any of the following: Clinically meaningful ascites, hepatic encephalopathy or history of hepatic encephalopathy, Child Pugh ≥8 points. The presence of clinically meaningful ascites is defined as any ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose. Subjects on stable doses of diuretics for ascites for ≥2 months are eligible.
- •Uncontrolled pleural effusion or pericardial effusion
- •Co-infection of HBV and HCV. Patients with a history of HCV infection but who are negative for HCV RNA by polymerase chain reaction (PCR) will be considered non-infected with HCV.
- •Prior systemic therapy for HCC (including previous CPI or VEGFi treatment)
- •Prior treatment with TACE or SIRT if active tumor recurrence is located in previously treated hepatic segment or recurrence within ≤ 6 months after prior TACE or SIRT
- •Ineligibility for locoregional treatment
结局指标
主要结局
Objective Response Rate (ORR compared to SIRT historical control)
Objective Response Rate (ORR compared to SIRT historical control)
次要结局
- Overall survival (OS)
- Progression-free survival (PFS)
- Complete response rate (CRR)
- Disease control rate (DCR)
- Duration of response (DoR)
- Time to deterioration of liver function, defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥30 days for any of these parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, albumin, and international normalized ratio (INR); separately for patients in Arm A and Arm B
- Time to locally/locoregional untreatable progression (TTuP), defined as time from randomization to occurrence of any of the following conditions: progression which would require targeting of more than 3 pretreated lesions as determined by the latest staging investigation, progression occurring due to diffuse tumor growth, occurrence of vascular invasion, occurrence of extrahepatic spread, worsening of liver function to Child-Pugh score 8 or higher
- Time to stage progression (defined as time from randomization to disease progression to BCLC C)
- To assess the quality of life (QoL), as determined by the EORTC QLQ-C30 and EORTC QLQ-HCC18 questionnaires.
研究者
Prof. Dr. med. Max Seidensticker
Scientific
Klinikum der Universitaet Muenchen AöR
研究点 (6)
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