NCT07691632 Serplulimab Adenocarcinoma of large intestine Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07691632 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: 21 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07691632 is a hot trial to watch
Adenocarcinoma of large intestine is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07691632 is notable because it evaluates Serplulimab in a Phase 2 design sponsored by Tianjin Medical University Cancer Institute and Hospital. 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 | NCT07691632 |
| Official title | Serplulimab Plus Decitabine and CAPOX Before Surgery for Locally Advanced Colorectal Cancer |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Serplulimab |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Geography | China |
| Enrollment | 35 |
| Primary endpoint | Pathological Complete Response Rate |
| Endpoint time frame | 2 to 4 weeks after completion of four cycles of neoadjuvant therapy, approximately 14 to 16 weeks after the first dose |
| Primary completion / readout proxy | 2027-12-31 |
Protocol design and endpoint interpretation
Title:A Single-Arm, Single-Center, Phase II Exploratory Study of Serplulimab Combined with Decitabine plus CAPOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer Background:Colorectal cancer is one of the most common gastrointestinal malignancies worldwide. Patients with locally advanced colorectal cancer remain at high risk of recurrence and distant metastasis after surgery. Although perioperative chemotherapy has improved clinical outcomes, the pathological complete response rate remains limited. Immune checkpoint inhibitors have shown remarkable efficacy in dMMR/MSI-H colorectal cancer; however, most pMMR/MSS tumors respond poorly to immunotherapy alone. Decitabine, a DNA methyltransferase inhibitor, may enhance tumor immunogenicity by promoting tumor antigen expression, improving antigen presentation, increasing immune cell infiltration, and reshaping the tumor immune microenvironment. CAPOX chemotherapy may further ind
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 35 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 (2 to 4 weeks after completion of four cycles of neoadjuvant therapy, approximately 14 to 16 weeks after the first dose) — Pathological complete response rate is defined as the proportion of participants with no residual viable tumor cells in the primary tumor and resected lymph nodes in surgical specimens after neoadjuvant therapy.
Readout outlook and evidence gap
The current protocol points to 2027-12-31 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
Trial-sourced asset: Serplulimab. The Drug & Asset MCP enrichment step is designed to add normalized targets, modality and global development status when an exact asset match is available.
Trial-sourced sponsor: Tianjin Medical University Cancer Institute and Hospital. Company & Deal Intelligence MCP is the companion workflow for resolving organization identity, corporate profile and partnering context.
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
NCT07691632 provides a focused lens on Adenocarcinoma of large intestine development. Its value will be determined by whether Serplulimab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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