NCT07487662 Sintilimab 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 NCT07487662 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 NCT07487662 is a hot trial to watch
Hepatocellular Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07487662 is notable because it evaluates Sintilimab in a Phase 2 design sponsored by Sun Yat-Sen 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 | NCT07487662 |
| Official title | TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk (ACTION-001) |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Sintilimab |
| Sponsor | Sun Yat-Sen University |
| Geography | Not reported in the indexed record |
| Enrollment | not reported |
| Primary endpoint | 1-year recurrence-free survival rate |
| Endpoint time frame | One year |
| Primary completion / readout proxy | not reported |
Protocol design and endpoint interpretation
Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide. The recurrence rate after curative resection for early-stage HCC remains extremely high, with 2-year and 5-year recurrence rates reaching 50% and 70%, respectively. Currently, no standard perioperative treatment is recommended in domestic and international guidelines. Recently, data from a phase III clinical study, investigating neoadjuvant and adjuvant therapy with camrelizumab plus apatinib in resectable HCC patients at intermediate-to-high risk of recurrence, demonstrated that the neoadjuvant and adjuvant therapy combining targeted therapy and immunotherapy could significantly reduce postoperative recurrence. The median recurrence-free survival (RFS) in the target-immunotherapy group was 42.1 months, which was remarkably longer than 19.4 months in the surgery-alone group. Local therapies (TACE, ablation) can induce immunogenic cell deat
Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment was not reported; study geography in Not reported in the indexed record 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.
- 1-year recurrence-free survival rate(One year) — The proportion of subjects who did not experience tumor recurrence or death within 1 year after surgery.
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: Sintilimab 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: Sun Yat-Sen University is resolved to a normalized organization record in Guangzhou, China. 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
NCT07487662 provides a focused lens on Hepatocellular Carcinoma development. Its value will be determined by whether Sintilimab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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