AI-Guided First-Line Immunotherapy Selection in Unresectable Hepatocellular Carcinoma

Official record

Identifier

NCT07729618

Recruiting locations

country

China

Interventions studied

AI-Assisted Clinical Decision Support StrategyUsual-Care Multidisciplinary Treatment-Selection Strategy

Lead sponsor

Tongji Hospital

Target enrolment

1800 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Not yet recruiting

First posted

Jul 27, 2026

Last updated on the registry

Jul 27, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Age 18 years or older.
* Hepatocellular carcinoma confirmed by histology or cytology, or diagnosed using accepted noninvasive radiologic criteria.
* Unresectable hepatocellular carcinoma for which first-line systemic therapy is indicated, including Barcelona Clinic Liver Cancer stage B disease that is unsuitable for or no longer benefiting from locoregional therapy, or stage C disease.
* No prior systemic anticancer therapy for unresectable hepatocellular carcinoma.
* Child-Pugh class A liver function.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Eligible and intended to receive at least one protocol-specified, guideline-concordant immune checkpoint inhibitor-based first-line regimen, as determined by the treating clinician before exposure to the study AI recommendation.
* Eligibility confirmed and prospective participant registration completed before the final first-line treatment regimen is selected.
* Baseline contrast-enhanced computed tomography or magnetic resonance imaging suitable for assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 is available before initiation of first-line systemic therapy.
* Required pretreatment clinical data are available within the protocol-specified assessment windows.
* Able to provide written informed consent.

Exclusion Criteria:

* Known combined hepatocellular-cholangiocarcinoma or another primary liver malignancy other than hepatocellular carcinoma.
* A contraindication or clinical condition that makes all protocol-specified immune checkpoint inhibitor-based first-line regimens inappropriate according to applicable prescribing information and routine clinical practice.
* Initiation of systemic therapy or completion of the final first-line regimen decision before prospective participant registration.
* Exposure of the treating clinical team to the participant-specific AI recommendation before confirmation of eligibility and registration.
* Concurrent anticancer treatment for another malignancy that would materially interfere with treatment selection or study outcome assessment.
* Planned participation in another interventional study that dictates first-line systemic treatment or would interfere with study outcome assessment.
* Inability to undergo protocol-required tumor imaging or follow-up assessments.