ChiCTR2600127362 SOX and sintilimab 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 ChiCTR2600127362—A multicenter,open-label, randomized controlled phase II clinical study evaluating the efficacy and safety of fuyiquitinib combined with sintilimab and SOX versus sintilimab combined with SOX in neoadjuvant treatment for resectable locally advanced gastric/gastroesophageal junction adenocarcinoma—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 ChiCTR2600127362 is a hot trial to watch
Locally Advanced Gastroesophageal Junction Adenocarcinoma is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. ChiCTR2600127362 is notable because it evaluates SOX and sintilimab in a Phase 2 design while The primary endpoint is pathological complete response (pCR), defined as the absence of residual tumor in both the primary tumor and lymph nodes (ypT0N0), assessed by postoperative pathological examination. 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 | ChiCTR2600127362 |
| Official title | A multicenter,open-label, randomized controlled phase II clinical study evaluating the efficacy and safety of fuyiquitinib combined with sintilimab and SOX versus sintilimab combined with SOX in neoadjuvant treatment for resectable locally advanced gastric/gastroesophageal junction adenocarcinoma |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | SOX and sintilimab, SOX+ fuquinitinib + sintilimab, SOX+信迪利单抗, SOX+呋喹替尼+信迪利单抗 |
| Sponsor | Not reported |
| Collaborators | Not reported |
| Geography | China |
| Enrollment | 60 |
| Primary endpoint | The primary endpoint is pathological complete response (pCR), defined as the absence of residual tumor in both the primary tumor and lymph nodes (ypT0N0), assessed by postoperative pathological examination. |
| Endpoint time frame | At the time of pathological assessment after curative surgery |
| Primary completion / readout proxy | [object Object] |
Design and endpoint interpretation
The phase label is only the starting point. Allocation is Not reported, masking is Open Label, and the intervention model is Parallel Assignment. Planned enrollment of 60 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.
- Secondary: Assessed using validated quality-of-life questionnaires (e.g., EORTC QLQ-C30 or QLQ-STO22 or EQ-5D-5L) (At baseline (prior to neoadjuvant therapy), at cycle 3 of neoadjuvant therapy, and prior to surgery;)
- Primary: The primary endpoint is pathological complete response (pCR), defined as the absence of residual tumor in both the primary tumor and lymph nodes (ypT0N0), assessed by postoperative pathological examination. (At the time of pathological assessment after curative surgery)
- Secondary: Assessed through follow-up or survival records (From randomization to death from any cause)
- Secondary: Assessed by postoperative pathological examination (At the time of pathological assessment after curative surgery)
- Secondary: Assessed based on imaging assessments and clinical follow-up (From randomization to disease progression, recurrence, failure to undergo surgery, or death)
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.
Build a living trial monitor: connect to PatSnap MCP Servers and track status changes, endpoint revisions, primary-completion dates and newly indexed results without manually reconciling separate databases.
Asset and sponsor context
Drug & Asset context: Not reported
Company & Deal Intelligence context: Not reported
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
ChiCTR2600127362 is a focused lens on Locally Advanced Gastroesophageal Junction Adenocarcinoma development. Its value will be determined by whether SOX and sintilimab can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.
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