Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07585279 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.
Metastatic Colorectal Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07585279 is notable because it evaluates Irinotecan Hydrochloride Lioposome (Hunan Jingfeng) in a Phase 2/3 design sponsored by The Fourth Hospital of Hebei Medical University. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
| Field | Indexed detail |
|---|---|
| Registration | NCT07585279 |
| Official title | A Clinical Study of Liposomal Irinotecan for Second-Line Therapy in Metastatic Colorectal Cancer |
| Phase / status | Phase 2/3 / Not yet recruiting |
| Intervention | Irinotecan Hydrochloride Lioposome (Hunan Jingfeng) |
| Sponsor | The Fourth Hospital of Hebei Medical University |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | ORR |
| Endpoint time frame | Around 4 years |
| Primary completion / readout proxy | [object Object] |
Phase II - Treatment Regimen Exploration Stage: 1. Evaluate the safety and efficacy of the following three treatment regimens: Liposomal irinotecan + 5-FU/LV + bevacizumab + Enlonstobart (Group A) Liposomal irinotecan + 5-FU/LV + bevacizumab (Group B) Irinotecan + 5-FU/LV + bevacizumab (Group C) 2. Provide a basis for selecting the treatment regimen for the confirmatory phase. 3. Explore the relationship between tumor tissue, stool, and blood biomarkers and efficacy and adverse reactions in liposomal irinotecan combination regimens versus irinotecan combination regimens. Phase III - Efficacy Confirmation Stage: Compare the efficacy and safety of liposomal irinotecan combination regimens versus irinotecan combination regimens in second-line treatment of metastatic colorectal cancer.
Allocation is Randomized, masking is None (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.
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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Drug & Asset MCP profile: Irinotecan Hydrochloride Lioposome (Hunan Jingfeng) 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: The Fourth Hospital of Hebei Medical 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.
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.
NCT07585279 provides a focused lens on Metastatic Colorectal Carcinoma development. Its value will be determined by whether Irinotecan Hydrochloride Lioposome (Hunan Jingfeng) 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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