ChiCTR2600125457 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 ChiCTR2600125457 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: 3 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why ChiCTR2600125457 is a hot trial to watch
Advanced Hepatocellular Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. ChiCTR2600125457 is notable because it evaluates Regorafenib in a Phase 2/3 design sponsored by Zhongshan Hospital Fudan University. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | ChiCTR2600125457 |
| Official title | A prospective, randomized, positive drug parallel - controlled, open - label, multi - center phase II/III registrational clinical study of SH006 injection in combination therapy compared with regorafenib for the treatment of advanced hepatocellular carcinoma across the country. |
| Phase / status | Phase 2/3 / Not yet recruiting |
| Intervention | Regorafenib |
| Sponsor | Zhongshan Hospital Fudan University |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | Safety-related observation results such as adverse events. |
| Endpoint time frame | Not reported |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The indexed record describes a Phase 2/3 study of Regorafenib in Advanced Hepatocellular Carcinoma.
Allocation is not reported, masking is Open Label, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across China 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.
- Safety-related observation results such as adverse events. (time frame not reported)
- Progression-Free Survival (PFS) (time frame not reported)
- Overall Survival (time frame not reported)
Readout outlook and evidence gap
The current protocol points to [object Object] 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 Small molecule drug, with target BRAF V600E x CRAF x CSF-1R x DDR2 x EphA2 x FGFR1 x FRK x MAPK11 x PDGFRα x PDGFRβ x RET x Tie-2 x TrkA x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit, mechanism BRAF V600E inhibitors, CRAF inhibitors, CSF-1R antagonists, and global highest development status Approved.
Company & Deal Intelligence MCP profile: Zhongshan Hospital Fudan University did not return an exact normalized organization match in this snapshot. 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
ChiCTR2600125457 provides a focused lens on Advanced Hepatocellular Carcinoma development. Its value will be determined by whether Regorafenib can convert the current Phase 2/3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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