NCT07745296 Futibatinib Intrahepatic Cholangiocarcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07745296 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: 5 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07745296 is a hot trial to watch
Intrahepatic Cholangiocarcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07745296 is notable because it evaluates Futibatinib in a Phase 3 design sponsored by UNICANCER. 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 | NCT07745296 |
| Official title | Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer (SAFIR-IMPACT) |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Futibatinib |
| Sponsor | UNICANCER |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Relapse-free survival |
| Endpoint time frame | From randomisation to disease or death, up to 5 years |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The objective of SAFIR-IMPACT BTC is to see whether, combining or replacing the standard adjuvant chemotherapy with a targeted therapy matched to the person's cancer, is better than the standard treatment alone in delaying or preventing the return of the cancer. Three different targeted therapies will be evaluated, each of which recognises a different type of abnormality in cancer cells: * Ivosidenib - a drug which acts on a specific abnormality in a protein called IDH1. * Futibatinib - a drug which acts on abnormalities in a protein called FGFR2 * Zanidatamab - a drug which acts on cancers that produce more than the usual quantity of a protein called HER2. The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a sample of the patient's tumour will be tested to see if it has one of the target abnormalities being studied (ii) a randomised comparative phase (for selected
Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel 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.
- Relapse-free survival (From randomisation to disease or death, up to 5 years) — Time from randomisation to the first documented relapse of disease, as assessed by the investigator, or death from any cause, whichever occurs first
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: Futibatinib 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: UNICANCER is resolved to a normalized organization record in France. 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
NCT07745296 provides a focused lens on Intrahepatic Cholangiocarcinoma development. Its value will be determined by whether Futibatinib can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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