NCT07636798 Envafolimab Advanced biliary tract cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07636798 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: 7 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07636798 is a hot trial to watch

Advanced biliary tract cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07636798 is notable because it evaluates Envafolimab in a Phase 1/2 design sponsored by West China Hospital. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

Advanced biliary tract cancer has a poor prognosis and limited efficacy with current regimens. This multicenter single-arm phase Ib/II trial explores the efficacy and safety of HAI-GP chemotherapy combined with intraoperative arterial envafolimab and lenvatinib as first-line therapy for unresectable BTC. It conducts dose exploration to confirm the optimal dosage and evaluates clinical outcomes, aiming to establish a better comprehensive treatment strategy.

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.

• Primary endpoint for Phase Ib: Dose-Limiting Toxicity (DLT) (Within 28 days after first dose (one safety observation cycle)) — The DLT observation period extends from the first dose to 28 days post-administration. If, among 9 patients enrolled in Phase Ib, the number experiencing DLT is ≤1 ，the dose level will be considered well tolerated; if the number is ≥2, dose reduction and re-evaluation will be required until a well-tolerated dose is established as the Recommended Phase II Dose (RP2D).
• Primary endpoint for Phase II:Objective Response Rate (ORR) (Every 6 weeks (every two 21-day treatment cycles), up to completion of maximum six 21-day combination treatment cycles) — Primary endpoint for Phase II:Objective Response Rate (ORR), defined as the proportion of patients achieving a predefined reduction in tumor volume maintained for the minimum required duration, including Complete Response (CR) and Partial Response (PR).

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: Envafolimab 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: West China Hospital is resolved to a normalized organization record in Chengdu, 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

NCT07636798 provides a focused lens on Advanced biliary tract cancer development. Its value will be determined by whether Envafolimab can convert the current Phase 1/2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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