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TACE-3: A two-arm multi-stage (TAMS) seamless phase II/III randomised trial of nivolumab in combination with TACE/TAE for patients with intermediate stage HCC

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513882-38-00
Acronym
ISRCTN12053408
Enrollment
11
Registered
2024-11-08
Start date
2022-10-12
Completion date
Unknown
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermediate stage Hepatocellular carcinoma

Brief summary

Phase II component : Time to TACE/TAE Progression (TTTP), Phase III component : Overall Survival

Detailed description

Phase II component : Number of Grade 3+ AEs and SAEs, Phase II component : Progression Free Survival (PFS), Phase II component : Time to progression (TTP), Phase II component : Response rate by RECIST 1.1, Phase III component : Time to TACE/TAE Progression (TTTP), Phase III component : Number of Grade 3+ AEs and SAEs, Phase III component : Progression Free Survival (PFS), Phase III component : Time to progression (TTP), Phase III component : Objective response rate (ORR) by RECIST 1.1, Phase III component : EORTC QLQ_C30 EORTC QLQ-HCC18 EQ5D

Interventions

DRUGDOXORUBICIN
DRUGEPIRUBICIN
DRUGCISPLATIN
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGMITOMYCIN
DRUGLIPIODOL ULTRA FLUIDE 480 mg/ml
DRUGsolution injectable
DRUGIDARUBICIN

Sponsors

The Clatterbridge Cancer Centre NHS Foundation Trust
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase II component : Time to TACE/TAE Progression (TTTP), Phase III component : Overall Survival—

Secondary

MeasureTime frame
Phase II component : Number of Grade 3+ AEs and SAEs, Phase II component : Progression Free Survival (PFS), Phase II component : Time to progression (TTP), Phase II component : Response rate by RECIST 1.1, Phase III component : Time to TACE/TAE Progression (TTTP), Phase III component : Number of Grade 3+ AEs and SAEs, Phase III component : Progression Free Survival (PFS), Phase III component : Time to progression (TTP), Phase III component : Objective response rate (ORR) by RECIST 1.1, Phase III component : EORTC QLQ_C30 EORTC QLQ-HCC18 EQ5D—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026