A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1003 in Combination with Lenvatinib Compared to Placebo in Combination with Lenvatinib as First-Line Therapy in Subjects with Advanced Hepatocellular Carcinoma (HCC)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517331-48-00

Acronym

CS1003-305

Enrollment

Registered

2024-10-29

Start date

2021-01-18

Completion date

2025-11-28

Last updated

2025-08-18

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

Conditions

Unresectable advanced hepatocellular carcinoma

Brief summary

Overall survival

Detailed description

Objective response rate

Interventions

DRUGCS1003

DRUGPlacebo

DRUGLENVATINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Objective response rate	—

Countries

Poland, Spain

Outcome results

None listed

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