NCT07621562 Sintilimab Advanced Gastric 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 NCT07621562 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: 23 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07621562 is a hot trial to watch
Advanced Gastric Adenocarcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07621562 is notable because it evaluates Sintilimab in a Phase 2 design sponsored by The First Affiliated Hospital, Zhejiang University Sch of Med. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07621562 |
| Official title | Tafolecimab Combined With Sintilimab and SOX in the Treatment of pMMR/MSS Gastric Cancer |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Sintilimab |
| Sponsor | The First Affiliated Hospital, Zhejiang University Sch of Med |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | Objective Response Rate |
| Endpoint time frame | At the end of Cycle 2 (each cycle is 21 days) |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
Background: Gastric cancer remains a significant health burden globally, particularly in China, where the majority of patients present with advanced disease at diagnosis. While immune checkpoint inhibitors (ICIs) targeting PD-1 have revolutionized treatment for various malignancies, their efficacy in proficient mismatch repair (pMMR) or microsatellite stable (MSS) gastric cancer-which constitutes over 85% of cases-remains limited. Recent Phase III trials (CheckMate 649, ATTRACTION-04, Orient-16) have demonstrated that combining PD-1 inhibitors with chemotherapy improves outcomes in advanced gastric cancer, leading to approved indications. However, the benefit in pMMR/MSS populations is modest, highlighting an urgent need for novel combination strategies to overcome immunotherapy resistance. Preclinical research published in Nature (Liu et al., 2020) revealed that inhibiting PCSK9 (Proprotein Convertase Subtilisin/Kexin type 9)-a key reg
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group 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.
- Objective Response Rate (At the end of Cycle 2 (each cycle is 21 days)) — Evaluate ORR and DCR (CR/PR/SD/PD) according to RECIST v1.1
Readout outlook and evidence gap
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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Asset and sponsor context
Drug & Asset MCP profile: Sintilimab is indexed as Monoclonal antibody, with target PD-1, mechanism PD-1 inhibitors, and global highest development status Approved.
Company & Deal Intelligence MCP profile: The First Affiliated Hospital, Zhejiang University Sch of Med did not return an exact normalized organization match in this snapshot. 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
NCT07621562 provides a focused lens on Advanced Gastric Adenocarcinoma development. Its value will be determined by whether Sintilimab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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