Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07788001 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: 1 September 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Esophageal Squamous Cell Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07788001 is notable because it evaluates Indocyanine Green in a Phase 3 design sponsored by Fujian Medical University Union Hospital. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
| Field | Indexed detail |
|---|---|
| Registration | NCT07788001 |
| Official title | A Non-inferiority Study of Indocyanine Green-guided Sentinel Lymph Node Mapping Versus Conventional Lymph Node Dissection in Esophageal Cancer (SIGN) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Indocyanine Green |
| Sponsor | Fujian Medical University Union Hospital |
| Geography | China |
| Enrollment | 200 |
| Primary endpoint | 3-year Disease free survival rate |
| Endpoint time frame | The time from randomization to the first occurrence of any of the following events (local recurrence, regional lymph node recurrence, distant metastasis, or death from any cause), assessed up to 36 months. |
| Primary completion / readout proxy | Not reported |
In the comprehensive treatment system for esophageal cancer, surgical resection combined with regional lymph node dissection remains the core component for achieving cure in patients with resectable esophageal squamous cell carcinoma (ESCC). The traditional surgical concept holds that the more thorough the lymph node dissection, the better. However, increasing basic and clinical evidence indicates that lymph nodes without metastasis-particularly tumor-draining lymph nodes-play an irreplaceable role in maintaining the host's anti-tumor immune response. Preclinical studies have found that radiation exposure to tumor-draining lymph nodes can impair the efficacy of radiotherapy combined with immunotherapy. In the surgical field, this shift in understanding has given rise to an important clinical question: in radical esophagectomy for esophageal cancer, is it possible to maximally preserve non-metastatic normal lymph nodes while ensuring com
Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of 200 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.
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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Drug & Asset MCP profile: Indocyanine Green 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: Fujian Medical University Union Hospital is resolved to a normalized organization record in Fuzhou, 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.
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.
NCT07788001 provides a focused lens on Esophageal Squamous Cell Carcinoma development. Its value will be determined by whether Indocyanine Green can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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