Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07586813 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: 24 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Thrombocytopenia is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07586813 is notable because it evaluates Tretinoin in a Phase 2 design sponsored by Peking University People's 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 | NCT07586813 |
| Official title | Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors (N01-A-PICIT-GI) |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Tretinoin |
| Sponsor | Peking University People's Hospital |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | Overall Platelet Response Rate at Week 12 |
| Endpoint time frame | From randomization to Week 12 |
| Primary completion / readout proxy | [object Object] |
This is a prospective, randomized, open-label, active-controlled study to evaluate the efficacy and safety of Romiplostim N01 plus all-trans retinoic acid (ATRA) compared with Romiplostim N01 alone in adults with persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after complete remission of gastrointestinal/digestive system solid tumors, including but not limited to gastrointestinal tract, pancreatic, and colorectal cancers. Eligible participants will be randomized in a 1:1 ratio to receive Romiplostim N01 plus oral ATRA or Romiplostim N01 alone for 12 weeks, with follow-up through Week 24. The primary outcome is the overall platelet response rate at Week 12, defined as platelet count >50 x 10^9/L in at least 2 of the last 3 scheduled platelet assessments up to Week 12. Secondary outcomes include sustained response during Weeks 13 to 24, complete and partial response rates, duration of response, time to response, platelet
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: Tretinoin is indexed as Small molecule drug, with target RARs, mechanism RARs agonists, and global highest development status Approved.
Company & Deal Intelligence MCP profile: Peking University People's Hospital is resolved to a normalized organization record in Beijing Shi, 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.
NCT07586813 provides a focused lens on Thrombocytopenia development. Its value will be determined by whether Tretinoin can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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