NCT07457775 Temozolomide Refractory Soft Tissue Sarcoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07457775 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: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07457775 is a hot trial to watch

Refractory Soft Tissue Sarcoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07457775 is notable because it evaluates Temozolomide in a Phase 2 design sponsored by The Second Affiliated Hospital Zhejiang University. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

The study is expected to include 24 patients with metastatic or surgically unresectable relapsed/refractory soft tissue sarcoma confirmed by histological evidence, who have received at least one line of systemic treatment previously. The efficacy and safety of liposome irinotecan combined with temozolomide and bevacizumab in the treatment of relapsed/refractory soft tissue sarcoma will be evaluated.

Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 24 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.

• Progression-free survival (PFS) (through study completion， assessed up to 24 months) — Progression-free survival (PFS) is a measure used in clinical trials and medical research to evaluate the effectiveness of treatments, especially in oncology. It refers to the length of time during and after treatment that a patient lives with a disease without it getting worse. In other words, PFS is the duration from the start of treatment until the disease progresses or until the patient dies from any caus，whichev
• Safety-Adverse events (AE) (through study completion，assessed up to 24 months) — Adverse events (AE)/serious adverse events (SAE) (judged based on NCI-CTCAE 5.0), etc.

Readout outlook and evidence gap

The current protocol points to 2028-01-31 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: Temozolomide 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 Second Affiliated Hospital Zhejiang University is resolved to a normalized organization record in Hangzhou, 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

NCT07457775 provides a focused lens on Refractory Soft Tissue Sarcoma development. Its value will be determined by whether Temozolomide can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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