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 - Zugspitze

Clinics of Munich University LM0 个研究点目标入组 84 人开始时间: 2021年5月31日最近更新: 2024年8月5日

适应症

试验速览

暂无简介。

•* 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 TACE with tumor burden < 50% of liver volume
•* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•* Preserved liver function, as defined by a Child-Pugh score A and serum Bilirubin <1.5 x institutional upper limit of normal (ULN)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 56
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 28

•* Diffuse HCC or presence of vascular invasion or extrahepatic spread (including extrahepatic lymph node affection or metastasis) or more than 7 lesions or at least one lesion = 7 cm
•* 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 =7 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.
•* Patients on a liver transplantation list
•* Prior systemic therapy for HCC (including previous CPI or VEGFi treatment)
•* Prior treatment with TACE or SIRT
•* Ineligibility for locoregional treatment
•* Major gastrointestinal bleeding within 4 weeks prior to inclusion

发起方

Clinics of Munich University LM