NCT07514533 Pucotenlimab Advanced Bile Duct Carcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07514533 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: 26 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07514533 is a hot trial to watch
Advanced Bile Duct Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07514533 is notable because it evaluates Pucotenlimab in a Phase 2 design sponsored by Sir Run Run Shaw 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 | NCT07514533 |
| Official title | The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Pucotenlimab |
| Sponsor | Sir Run Run Shaw Hospital |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Objective response rate (ORR) |
| Endpoint time frame | 2 year |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
(1) Primary efficacy endpoint: Objective Response Rate (ORR) after 2 treatment cycles. ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) among all subjects. (2) Secondary efficacy endpoints include Progression-Free Survival (PFS), 2-year Relapse-Free Survival Rate, Disease Control Rate (DCR), Duration of Response (DOR), Adverse Reaction Incidence, 1-year Overall Survival Rate, 2-year Overall Survival Rate. Safety assessment includes physical examination, physical condition assessment (based on ECOG score), clinical laboratory tests and concomitant medication status. All observed drug toxicities and side effects need to be classified according to NCICTCAE and evaluated for their correlation with the drug. Patient Quality of Life (QoL) assessment uses the EORTC QLQC30 questionnaire and the BIL21 questionnaire. Recurrence patterns are classified as local recurrence and distant recurrence. Lo
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record 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 (ORR) (2 year)
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: Pucotenlimab 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: Sir Run Run Shaw Hospital is resolved to a normalized organization record in Hangzhou, 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
NCT07514533 provides a focused lens on Advanced Bile Duct Carcinoma development. Its value will be determined by whether Pucotenlimab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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