NCT07483567 Tegafur/Gimeracil/Oteracil Potassium Locally Advanced Gastroesophageal Junction Adenocarcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07483567 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 NCT07483567 is a hot trial to watch

Locally Advanced Gastroesophageal Junction Adenocarcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07483567 is notable because it evaluates Tegafur/Gimeracil/Oteracil Potassium in a Phase 2 design sponsored by Innovent Biologics (Suzhou) Co. Ltd.. 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

This study is a prospective, randomized, open, multicenter phase II clinical trial. It plans to enroll 70 participants with locally advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJ AC) who are assessed as suitable for D2 radical surgery and capable of R0 resection.To evaluate the clinical efficacy and tolerability of IBI343 in combination with sintilimab and SOX regimen for perioperative treatment of resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma.Enroll patients who are CLDN18.2 positive.

Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of 90 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.

• Pathological complete response rate (pCR rate): defined as the proportion of participants who, after surgery, show complete regression of tumor cells in the primary lesion and lymph node lesions according to pathological examination. (Up to 4 years)
• Dose-limiting toxicity (DLT), to determine MTD and/or RP2D (Up to 4 years)

Readout outlook and evidence gap

The current protocol points to 2030-06-30 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: Tegafur/Gimeracil/Oteracil Potassium 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: Innovent Biologics (Suzhou) Co. Ltd. is resolved to a normalized organization record in Suzhou, 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

NCT07483567 provides a focused lens on Locally Advanced Gastroesophageal Junction Adenocarcinoma development. Its value will be determined by whether Tegafur/Gimeracil/Oteracil Potassium can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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