NCT07673887 Leucovorin Calcium Locally Advanced Gastroesophageal Junction Adenocarcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready landscape. This focused report examines NCT07673887—A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.
MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.
Why NCT07673887 is a hot trial to watch
Locally Advanced Gastroesophageal Junction Adenocarcinoma is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. NCT07673887 is notable because it evaluates Leucovorin Calcium in a Phase 3 design while OS is defined as the time from the date of randomization until the documented date of death from any cause. serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.
PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07673887 |
| Official title | A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Leucovorin Calcium, Pembrolizumab, Oxaliplatin, ASP2138, 5-FU, Folinic acid, Capecitabine, Placebo for Pembrolizumab |
| Sponsor | Astellas Pharma Global Development, Inc. |
| Collaborators | Not reported |
| Geography | Not reported |
| Enrollment | 570 |
| Primary endpoint | OS is defined as the time from the date of randomization until the documented date of death from any cause. |
| Endpoint time frame | Up to 54 months |
| Primary completion / readout proxy | [object Object] |
Design and endpoint interpretation
The phase label is only the starting point. Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of 570 participants across Not reported 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.
- Primary: OS is defined as the time from the date of randomization until the documented date of death from any cause. (Up to 54 months)
- Primary: PFS is defined as the time from the date of randomization until the date of radiographic disease progression per RECIST V1.1 by BICR or death from any cause, whichever is earlier. (Up to 54 months)
- Secondary: ORR is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST V1.1 by BICR. (Up to 54 months)
- Secondary: DCR is defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD) based on RECIST V1.1 by BICR. (Up to 54 months)
- Secondary: DOR is defined as the time from the date of the first response (CR/PR) until the date of disease progression as per RECIST V1.1 by BICR or date of death from any cause, whichever is earlier. (Up to 54 months)
Benchmark readouts in the surrounding field
- Neoadjuvant tislelizumab plus oxaliplatin and S-1 for locally advanced Siewert type II esophagogastric junction adenocarcinoma: A prospective multicenter phase II study. (Phase 2): pCR = 25.0 %
- Perioperative chemotherapy plus disitamab vedotin (RC48) and toripalimab in HER2-overexpressed locally advanced gastric or gastroesophageal junction cancer (PERISCOPE-02): An open-label, single-arm, phase 2 trial. (Phase 2): Surgical morbidity(Clavien-Dindo II/III) = 8.0 %
- Long-term survival results of perioperative chemoimmunotherapy with DCF and avelumab in locally advanced gastro-esophageal adenocarcinoma. (Phase 2): DFS(5-year) = 100.0 % ; DFS(5-year) = 55.3 %
These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.
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Asset and sponsor context
Drug & Asset context: Leucovorin Calcium (Approved; target not reported); Pembrolizumab (Approved; PD-1); Oxaliplatin (Approved; DNA)
Company & Deal Intelligence context: Astellas Pharma Global Development, Inc. — United States
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 decide 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.
- Sequencing evidence: comparative data after the most 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 probability of success before a headline data release.
Bottom line
NCT07673887 is a focused lens on Locally Advanced Gastroesophageal Junction Adenocarcinoma development. Its value will be determined by whether Leucovorin Calcium can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.
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