A randomized, 2-arm non-comparative phase II study on the efficacy of atezolizumab and Roche bevacizumab (Atezo/Bev) followed by on-demand selective TACE (sdTACE) upon detection of disease progression or of initial synchronous treatment with TACE and Atezo/Bev on objective response rate in the treatment of unresectable hepatocellular carcinoma patients (DEMAND)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512682-14-00

Acronym

AIO-HEP-0418-DEMAND

Enrollment

100

Registered

2024-10-08

Start date

2020-04-06

Completion date

Unknown

Last updated

2026-01-15

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

Conditions

Non-resectable hepatocellular carcinoma (HCC)

Brief summary

To evaluate the efficacy of up-front atezolizumab/ bevacizumab (Atezo/Bev) followed by on-demand selective transarterial chemoembolization (sdTACE) and of initial synchronous treatment with TACE and Atezo/Bev in the treatment of unresectable HCC patients Corresponding primary endpoint: Objective response rate (according to RECIST v1.1) (as assessed by local investigator) (ORR)

Detailed description

To evaluate the efficacy, safety and quality of life of treatment with Atezo/Bev in combination with TACE Corresponding secondary endpoints:• Overall survival (OS) • 24-months survival rate • Progression-free survival (PFS) • Complete response rate (CRR) • Disease control rate (DCR) • Time to deterioration of liver function, defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥ 30 days for any of these parameters: aspartate aminotransferas

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
To evaluate the efficacy, safety and quality of life of treatment with Atezo/Bev in combination with TACE Corresponding secondary endpoints:• Overall survival (OS) • 24-months survival rate • Progression-free survival (PFS) • Complete response rate (CRR) • Disease control rate (DCR) • Time to deterioration of liver function, defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥ 30 days for any of these parameters: aspartate aminotransferas	—

Measure

Time frame

—

Primary

Measure	Time frame
To evaluate the efficacy of up-front atezolizumab/ bevacizumab (Atezo/Bev) followed by on-demand selective transarterial chemoembolization (sdTACE) and of initial synchronous treatment with TACE and Atezo/Bev in the treatment of unresectable HCC patients Corresponding primary endpoint: Objective response rate (according to RECIST v1.1) (as assessed by local investigator) (ORR)	—

Countries

Germany

Outcome results

None listed

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