CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 55 target
Drug / intervention
Tremelimumab +3 moredrug
Likely dose
Tremelimumab 300 mgfrom record
Key inclusion· 10
  • ✓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 per RECIST 1.1 on CT or MRI
Key exclusion· 24
  • ✕Diffuse HCC or vascular invasion or extrahepatic spread (except segmental portal vein invasion)
  • ✕Child-Pugh B or C cirrhosis
  • ✕Contraindications for hepatic embolization (hepatofugal flow, porto-systemic shunt, impaired clotting, renal failure, severe atheromatosis, total portal vein thrombosis/invasion)
  • ✕Locoregional therapy ongoing or completed <4 weeks prior to baseline

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT04522544Phase 2ActiveOn Track
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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 Nordwest·interventional·Posted Aug 21, 2020·Updated Jun 23, 2026

In Brief

A Phase 2 clinical trial evaluating Tremelimumab, Durvalumab, and 2 other interventions for Hepatocellular Carcinoma Non-resectable and HCC. Active but no longer recruiting, targeting 55 participants across 11 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma Non-resectable, HCC
CountriesGermany
CollaboratorsAstraZeneca, Hannover Medical School

Timeline

Phase 2Active
20212022202320242025202620272028
First PostedAug 21, 2020
Enrollment StartDec 15, 2020
Primary CompletionJul 31, 2027
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 5.9 years agoPrimary completion in 1.1 years

Arms & Interventions

SIRT (Arm A)experimental

Y-90 SIRT + Tremelimumab + Durvalumab

Drug: TremelimumabDrug: DurvalumabProcedure: Y-90 SIRT
TACE (Arm B)experimental

DEB-TACE + Tremelimumab + Durvalumab

Drug: TremelimumabDrug: DurvalumabProcedure: DEB-TACE

Interventions

Tremelimumabdrug

300 mg Tremelimumab C1D1

Durvalumabdrug

1500 mg Durvalumab C1D1 + Q4W (max. 13 cycles)

Y-90 SIRTprocedure

Locoregional therapy will be performed as a standard-of-care procedure

DEB-TACEprocedure

Locoregional therapy will be performed as a standard-of-care procedure