临床试验/NCT04522544

NCT04522544

招募中

2 期

A Phase II Study of Immunotherapy With Durvalumab (MEDI4736) and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest12 个研究点分布在 1 个国家目标入组 55 人2020年12月15日

适应症Hepatocellular Carcinoma Non-resectable HCC

干预措施Tremelimumab Durvalumab Y-90 SIRT DEB-TACE

概览

阶段: 2 期
干预措施: Tremelimumab
疾病 / 适应症: Hepatocellular Carcinoma Non-resectable
发起方: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
入组人数: 55
试验地点: 12
主要终点: Objective response rate (ORR) [according to RECIST 1.1] at 6 months.
状态: 招募中
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

A Phase II study of immunotherapy with Durvalumab (MEDI4736) and Tremelimumab in combination with Y-90 SIRT for intermediate stage HCC

详细描述

The IMMUWIN phase II will test the safety and anti-tumor efficacy of the combination of Durvalumab and Tremelimumab with Y-90 SIRT.

注册库

clinicaltrials.gov

开始日期

2020年12月15日

结束日期

2027年12月31日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

责任方

Sponsor

入排标准

入选标准

•Capable of giving written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
•Age ≥ 18 years at time of study entry.
•Body weight \> 30 kg.
•Multinodular or large, solitary HCC, not eligible for resection or local ablation.
•Histologically confirmed diagnosis of HCC.
•Scheduled to receive locoregional therapy as standard of care.
•At least one measurable site of disease as defined by RECIST 1.1criteria with spiral CT scan or MRI.
•No prior systemic anti-cancer therapy.
•Child-Pugh A.
•Performance status (PS) ≤ 1 (ECOG scale).

排除标准

•Diffuse HCC or presence of vascular invasion or extrahepatic spread with the following exception:
•o Invasion of a segmental portal vein or hepatic veins.
•Patients with advanced liver disease as defined below:
•o liver cirrhosis with stage Child Pugh B and C.
•Any contraindications for hepatic embolization procedures:
•Known hepatofugal blood flow;
•Known porto-systemic shunt;
•Impaired clotting test (platelet count \< 70 x 10\^9/L, INR \> 1.25);
•Renal failure/insufficiency requiring hemo-or peritoneal dialysis;
•Known severe atheromatosis;

研究组 & 干预措施

SIRT (Arm A)

Y-90 SIRT + Tremelimumab + Durvalumab

干预措施: Tremelimumab

SIRT (Arm A)

Y-90 SIRT + Tremelimumab + Durvalumab

干预措施: Durvalumab

SIRT (Arm A)

Y-90 SIRT + Tremelimumab + Durvalumab

干预措施: Y-90 SIRT

TACE (Arm B)

DEB-TACE + Tremelimumab + Durvalumab

干预措施: Tremelimumab

TACE (Arm B)

DEB-TACE + Tremelimumab + Durvalumab

干预措施: Durvalumab

TACE (Arm B)

DEB-TACE + Tremelimumab + Durvalumab

干预措施: DEB-TACE

结局指标

主要结局

Objective response rate (ORR) [according to RECIST 1.1] at 6 months.

时间窗: 6 months

Proportion of allocated subjects with best response of complete or partial response

次要结局

Overall response rate (ORR) as best overall response (BOR) during therapy(13 months)
Treatment related SAEs(From first patient included until study closure (approx. 42 months after First Patient Included))
Overall survival (OS)(From the date of treatment Date of enrollment until date of death if applicable (up to 42 months until Study Closure))
Overall response rate (ORR) at 6 months(6 months)
Progression free survival (PFS)(Time from the date of randomization to the date of first observed disease progression or death (approx. 42 months))
Quality of Life (QoL)(24 months)