Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC (NCT04522544) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC
Germany55 participantsStarted 2020-12-15
Plain-language summary
A Phase II study of immunotherapy with Durvalumab (MEDI4736) and Tremelimumab in combination with Y-90 SIRT for intermediate stage HCC
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Diffuse HCC or presence of vascular invasion or extrahepatic spread with the following exception:
. Patients with advanced liver disease as defined below:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR) [according to RECIST 1.1] at 6 months.
Timeframe: 6 months
Trial details
NCT IDNCT04522544
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
. Any contraindications for hepatic embolization procedures:
. Locoregional therapies ongoing or completed \< 4 weeks prior to the baseline scan.
. History of cardiac disease:
. Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
. Prior, systemic anti-cancer therapy, radiotherapy administered \< 4 weeks prior to study entry, endocrine- or immunotherapy or use of other investigational agents.
. Current or prior use of immunosuppressive medication within 14 days before the first dose of Durvalumab or Tremelimumab. The following are exceptions to this criterion: