NCT07495579 Regorafenib Advanced Hepatocellular Carcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07495579 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.

MCP evidence snapshot: 26 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07495579 is a hot trial to watch

Advanced Hepatocellular Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07495579 is notable because it evaluates Regorafenib in a Phase 2 design sponsored by Asan Medical Center. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

The goal of this clinical trial is to learn if lenvatinib or regorafenib can help treat people with advanced liver cancer (hepatocellular carcinoma, HCC) that cannot be removed with surgery after first treatment with immunotherapy-based drug combinations. It will also look at the safety of these treatments. The main questions this study aims to answer are: * How long lenvatinib can delay cancer growth in people with good liver function (Child-Pugh)A after dual immunotherapy * How long people with reduced liver function (Child-Pugh B7-B8) live after treatment with lenvatinib or regorafenib after first-line immunotherapy-based combination treatment * What side effects people experience during treatment * How many people have their tumors shrink or disappear The study has two parts: In REVIVE-1, participants with Child-Pugh A liver function will receive lenvatinib. In REVIVE-2, participants with Child-Pugh B7 to B8 liver function will rece

Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment was not reported; study geography in South Korea shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Progression-Free Survival (PFS) in REVIVE-1(Up to 24 months) — Progression-free survival is defined as the time from first dose of study treatment to disease progression according to RECIST v1.1 or death from any cause, whichever occurs first, in the REVIVE-1 cohort.
• Overall Survival (OS) in REVIVE-2(Up to 30 months) — Overall survival is defined as the time from first dose of study treatment to death from any cause in the REVIVE-2 cohort.

Readout outlook and evidence gap

The current protocol points to not reported as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.

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Asset and sponsor context

Drug & Asset MCP profile: Regorafenib is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.

Company & Deal Intelligence MCP profile: Asan Medical Center is resolved to a normalized organization record in South Korea. The organization workflow adds identity, location, portfolio and partnering context where available.

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.

Bottom line

NCT07495579 provides a focused lens on Advanced Hepatocellular Carcinoma development. Its value will be determined by whether Regorafenib can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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